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How to become a clinical research associate (CRA)

clinical research job requirements

Clinical research is an important step in developing and evaluating new medical products. For people with qualifications or experience within life sciences , a career in clinical research can offer many rewarding, interesting and varied opportunities and career paths . With the demand for new prevention methods and treatments ever increasing, clinical research associates are needed by pharma, biotech, medical device companies and CROs around the world. Here are some things to consider if you’re looking to kick-start a career in clinical research and how to become a clinical research associate:

What is a clinical research associate?

'A clinical research associate (CRA) is someone who monitors the running of clinical trials. A CRA may be involved in some or all stages of the clinical trials process depending on the type of position or the employer.

What are the responsibilities of a clinical research associate?

Typically, the key responsibilities of a CRA will include monitoring study sites and clinical activities, updating study documentation, maintaining clinical data systems and coordinating research procedures.

If you are a field-based CRA, you will spend most of your time travelling to different locations, dealing with medical professionals in trial centres, healthcare practices, or hospitals. The remainder of your time may be spent either office-based or working from home, but this will depend on the company. Some companies will have in-house CRA roles who just focus on document review and management and will make site visits only occasionally.

What is the demand for clinical research associates?

Driven by a rise in the number of healthcare facilities, increasing healthcare expenditure, technological and research capabilities, and an aging population, the need for new treatments has increased exponentially in recent times. This has led to a rise in the number of companies hiring for new clinical research jobs and this is likely to keep gaining momentum in the years to come.

What qualifications or training do I need to get a clinical research associate job?

A degree in a life science or other health-related discipline is usually needed to start a career in clinical research. However, there are courses and training available that can help you get a foot in the door if you haven’t got the desired qualifications.

Qualifications:

Although not usually necessary, a Master's degree (MSc. or equivalent) or a PhD can be advantageous and could give you valuable experience in clinical research. A relevant PhD can also be beneficial, as some companies will see this as relevant work experience and count it towards reaching promotions to more senior positions.

Certifications:

The Association of Clinical Research Professionals (ACRP) offers a certification exam to become a Certified CRA. Even though, for most CRA roles, this is not a requirement, being CCRA certified is a real advantage. The exam covers everything a CRA will need to know from scientific concepts and research design to product development and regulation, to data management.

There are lots of courses out there that can provide you with a detailed understanding of what it takes to a be CRA. Before you sign up to anything, make sure it is a recognised training course that is recommended by the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).

How do I get the right experience for a clinical research associate job?

Getting your first job in clinical research can be challenging, and many graduates at the start of their clinical research career can become frustrated by the 'catch 22' scenario: they can't find work because of a lack of experience and they can't get experience because they can't find work.

Without relevant work experience, you will be more likely to secure a job as a clinical trials assistant (CTA). A CTA role will help support all processes of the trial and give you the required experience to move into a clinical research assistant role.

Generally, larger companies are far better equipped to take-on inexperienced graduates and are more likely to offer programmes such as graduate assessment days and internships. Research who the top pharmaceutical companies , medical device manufacturers and contract research organisations are, and look out for opportunities on their career websites. Their social media pages are also great places to find out about graduate programmes, so keep a close eye on them too.

You might be able to gain experience by working on academic projects or working within a healthcare body. Although these are good ways to gain experience, moving into a commercial environment later can be quite different and you might have to take a more junior position with a lower salary than you are used to.

Tips for applying to clinical research jobs            

Even with all the relevant qualifications, skills and experience that you need to become a clinical research associate, there can still be challenges in landing your perfect clinical research job . A few simple changes to your approach can give your CV a better chance of success .

Be realistic

Be realistic about the types of jobs that you can attain. If you don’t have industry experience, you are unlikely to be hired for anything above an entry level role. Don't apply to senior CRA jobs or clinical project manager roles unless you have been working as a CRA for some time already and have the required experience. Save yourself the time and effort in making lots of speculative applications and take a more targeted approach.

Highlight your relevant experience

If you are applying for a clinical research associate job , ensure that you read each job description carefully and highlight on your CV the relevant experience that matches the specific description. Your cover letter should be personalised to the specific company and describe why you want to work for that company and which of your skills match the specific requirements of the role. Employers and life sciences recruitment consultants are looking for the most relevant applications and will readily discard those that have put little effort into personalising it.

Make sure you network

Remember, not every company will advertise all its vacancies so you should consider other approaches too. Networking with recruiters and hiring managers and uploading your CV to a database are two great ways that employers and recruiters with CRA jobs can find you.

What are the different career paths you can take?

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There are a variety of ways to progress your career in clinical research , with pharma, biotech, and medical device companies and CROs all offering opportunities. Roles will vary from company to company but typically CRAs will progress to be a senior clinical research associate. With the right experience, CRAs will have the potential to progress all the way to clinical director or even VP level.

Once a CRA has reached senior level, there are typically three main routes a career in clinical research can take. You will either be a manager of the trial process, a manager of people or a project manager.

Clinical trial management:

Usually responsible for managing, coordinating, and overseeing various aspects of the trial. Typical duties will involve supervising staff, implementing study tools and documents, overseeing trial budgets and providing strategic input into trials.

Clinical team management:

Responsible for acting as the direct line manager to associates. Clinical team managers will manage and support team members, ensure staff are trained effectively, review the effectiveness of business processes and plan professional development activities.

Clinical project management:

Involved with the planning and directing of clinical trials and is also responsible for evaluating clinical data. Day-to-day tasks include, maintaining study records, ensuring activities are being delivered on time and on budget, interpreting study data and developing trial plans.

Are you already a CRA professional or looking to start your career in clinical research? We might have something that is the right fit for you. We are looking for experienced professionals for a broad and extensive range of clinical research positions. Take a look at our latest clinical research jobs and apply today.

clinical research job requirements

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clinical research job requirements

What You Need to Know to Become a Clinical Research Associate

clinical research job requirements

A clinical research associate (CRA) is a professional who oversees clinical trials. Continue reading to find out what you need to know to become a Clinical Research Associate.

A clinical research associate (CRA) is a health care or life sciences professional who oversees clinical trials on behalf of pharmaceutical companies, medical research institutes and government agencies.

What You Need to Know to Become a Clinical Research Associate (CRA)

CRAs are sometimes called clinical monitors or trial monitors. A key part of the job is to monitor Good Clinical Practice (GCP) guidelines such as the ones developed by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Salary Range

CRAs tend to be classified by the Bureau of Labor Statistics (BLS) as clinical and medical informaticians.

As such, salaries range between $54,958 and $69,331 according to Salary.com , and the average salary for a CRA in 2022 was $62,432. Payscale.com cites a similar range, listing a median salary of $61,984 with a low of around $46,000 and a high of around $96,000.

Payscale also notes, “For a Clinical Research Associate, progressing to a Clinical Trial Manager role may result in a significant raise...Clinical Research Associates moving up in their careers tend to step into positions as Senior CRAs or Clinical Project Managers.”

Certification and Requirements

The Association of Clinical Research Professionals (ACRP) offers a certification exam to become a Certified Clinical Research Associate (CCRA). It is not a requirement to be CCRA certified to work as a CRA, but it does give one an advantage.

According to the ACRP, CRA certification eligibility includes documentation that one has worked independently of the investigative staff conducting research at a site or institution.

This means the employee does not report to the primary investigator or site manager and doesn’t have the ability to otherwise change or manipulate clinical trial data. These employees workk on behalf of the sponsor, which is generally a pharmaceutical or device company, a granting organization, a physician or a university department.

It also compiles a lengthy list of duties that the applicant must have performed for a cumulative 3,000 to 6,000 hours. The CCRA is designed for people already working as CRAs.

The role requires a bachelor’s degree or higher and 3,000 hours performing essential duties as an LPN, LVN or RN. One can also have an Associate’s Degree and a minimum of 4,500 hours performing essential duties, or work as a Medical Assistant, Lab Technician or have a High School Diploma and a minimum of 6,000 hours of performing essential duties.

To some, the CCRA certification seems like a Catch-22—in order to be certified, you need to already have the job, and to get the job, you need to be certified. However, there are ways to work with the system.

Short of a rather circular line of thinking—getting a job as a CRA to get experience as a CRA—there are educational courses. Numerous courses are online, but be careful—there are a lot of scams out there.

In that respect, it would be a good idea before taking a course to make sure it is recommended by the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).

Having a life science or medical degree is one the strongest educational backgrounds one can have for this position. Keeping in mind that ICH-GCP is the heart of being a CRA, any and all coursework on Good Clinical Practice as outlined by the ICH is also helpful.

It’s questionable if these are really shortcuts, or if shortcuts really exist, but here are a few ideas—or strategies—that might shorten the time to employment.

1. Working Up to the Role

Instead of attempting to jump right in, there are Clinical Research Coordinator (CRC) and Clinical Trial Assistant (CTA) jobs available that may be beneficial for those who are not ready to become a CRA right away.

2. Consider the Employers

Very broadly speaking, CRAs work for pharmaceutical companies or contract research organizations (CROs). A CRO handles much of the clinical trial work for biopharma companies, running the clinical trials and providing statistical analysis and resources.

Many people looking for CRA jobs may check the big companies first, ones like Johnson & Johnson or Pfizer. However, smaller biopharma companies, hospitals and even doctors’ offices may have a need for CRAs, and they will likely have less applicants for each role.

3. Take Relevant Coursework

Focus on coursework that falls under the GCP guidelines. This could be the best route for those who lack the necessary experience for an entry-level CRA position.

4. Don’t Only Apply for Advertised Positions

Admittedly, this seems counterintuitive. And by and large, big companies are going to post jobs and use recruiters. Smaller companies, though, may be more open to “spontaneous” applications.

Sending a cover letter to some companies that aren’t actively recruiting CRAs and clearly stating one’s intent could be a great, albeit unconventional, way to get a foot in the door.

All told, being a clinical research associate can be a fascinating, well-paying job with numerous opportunities. If you’re ready to make the switch and become a CRA, know that you’ll be making a positive difference not only for yourself but in the lives of the people and patients you serve.

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Clinical research roles: how to become a clinical research associate, clinical research associate job description.

Clinical research associates (CRAs) are key actors in facilitating and ensuring successful clinical trial operations. A CRA in clinical research plays an essential role in the trial’s logistics, acting as a liaison between trial sites and the sponsor, and interacting with patients.

What is a clinical research associate?

A clinical research associate (CRA) is responsible for ensuring that clinical trials follow regulations, protocols, and Good Clinical Practice (GCP) guidelines.[ 1 ] The job description of a clinical research associate is centered on monitoring clinical trials to ensure they are conducted safely and effectively, and facilitating communication and coherence between sites and the sponsor. Their duties could include:

  • Site selection: CRAs may be involved to varying degrees in selecting appropriate clinical trial sites as well as performing pre-trial site screening visits to verify their capacity to conduct the trial
  • Protocol development: CRAs may help the sponsor/investigators develop the clinical trial protocol
  • Study start up: CRAs assist with study start up activities, including obtaining regulatory approvals, collecting documentation, training site staff, and conducting site initiation visits
  • Site visits: A core responsibility of the CRA is to visit the trial sites, both during the trial (to ensure protocol and regulatory compliance), and after the trial (to perform site close-out)
  • Site monitoring: CRAs verify that sites are following the data management plan and protocols to help ensure data is accurate and complete
  • Safety monitoring: CRAs may monitor patient safety throughout the trial, including adverse event reporting and serious adverse event management
  • Regulatory compliance: CRAs ensure that clinical trials are conducted according to legal and ethical regulations and GCP guidelines

Other potential names for this position include clinical research monitor, clinical trials coordinator, clinical research scientist, or clinical research manager.

Qualifications: How to become a clinical research associate

To become a clinical research associate, you typically need a bachelor's degree in a relevant field such as biology, life sciences, or nursing. A degree in a field that is related to clinical research is generally preferred but is not required for all positions. Some employers may require additional qualifications, such as a master's degree or specialized certification.

In addition to formal education, experience working in the medical research industry is highly desirable. Many CRAs start their career in clinical research working under the supervision of experienced clinical research professionals.

Some of the skills needed to perform the job functions of a CRA include:

  • Strong attention to detail and organizational skills
  • Excellent communication and interpersonal skills
  • Ability to work both independently and as part of teams
  • Knowledge of the pharmaceutical and healthcare industries, health and life sciences, and clinical trial processes, regulations, and guidelines
  • Analytical and problem-solving skills
  • Proficiency in data management and analysis software

If you do not have a relevant degree or prior experience, there are still ways to break into the field of clinical research as a CRA. Here are a few tips:

  • Look for entry-level clinical research jobs: Many companies offer entry-level clinical research associate jobs for individuals who do not have prior experience in clinical research. These positions may involve assisting CRAs with managing study activities or administrative tasks.
  • Volunteer: Volunteering for clinical research organizations (CROs), research hospitals conducting trials, or other clinical research companies can provide valuable experience and demonstrate your interest in the field. Further, this experience may count as relevant work experience and could qualify you to take the ACRP CRA certification exam (see next section)

Clinical research associate certification

Several courses and clinical research certifications can help you land a CRA job. Two of the most in-demand clinical research associate certifications include SOCRA’s Certified Clinical Research Professional (CCRP) certification and the Association of Clinical Research Professionals (ACRP)’s Certified Clinical Research Associate (CCRA) certification.[ 2 ],[ 3 ] A CRA certification can help demonstrate your knowledge and skills to potential employers.

Similarly, the Certified Clinical Research Professionals Society (CCRPS) offers an Advanced Clinical Research Associate Certification (ACRAC) and course which covers clinical research protocols, clinical trials regulations set by the FDA, Good Clinical Practice (GCP), ICH guidelines, and more.[ 4 ] On a more general level, Coursera offers a specialized certification in Medical Terminology led by Rice University to help you get started on various career paths in the medical field.[ 5 ]

Where to look for clinical research associate jobs

Clinical research associates typically work for pharmaceutical companies, contract research organizations (CROs), academic institutions, or government agencies involved in conducting clinical research. They work closely with a team of clinical research professionals, including principal investigators (PIs), clinical research coordinators (CRC), data managers, and sponsors.

You may be able to find job openings directly with such companies by surveying their websites for open positions. However, you can also look for CRA jobs on job boards such as Indeed[ 6 ] or LinkedIn[ 7 ].

What is the average clinical research associate salary?

The average clinical research associate salary in the United States is around $81,826 (as of when this article was written), with a lower range of $49,052 and a higher range (senior clinical research associate salary) of around $136,499.[8] Salary will depend on multiple factors: level of experience, education, other certifications/qualifications, skillset, and the specific employer.

Clinical Research Associate job outlook

The job outlook for clinical research associates is quite positive, with the high demand for professionals in this field expected to continue. According to the Bureau of Labor Statistics, the employment of medical and health services managers, which includes clinical research associates, is projected to grow 28% between 2021 and 2031.[ 9 ]

In addition, the pharmaceutical and biotech industries are constantly developing new drugs and therapies, which must go through clinical trials before they can be approved. In the USA alone, there are currently over 400,000 active clinical trials.[ 10 ] Thus, there is high demand for professionals with the skills and knowledge to oversee these trials, ensure they are conducted safely and ethically, and optimize their success, particularly in the context of recent advances in technological adoption and new trial models. Moreover, CRA salaries have increased by an average of 15% over the past five years.[ 11 ]

Becoming a clinical research associate is a challenging yet rewarding career path requiring unique skills and qualifications. If you are passionate about medical research and want to make a difference in patients' lives, and you like working with diverse teams on large projects, this may be a promising career path for you. With the proper education, a CRA training program, and some relevant experience, you can become a vital part of the clinical research industry and contribute to the development of new treatments and therapies.

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Popular guides.

Clinical Research Roles: How to Become a Clinical Trial Manager

  • Job Descriptions
  • Healthcare and Medical Job Descriptions

Clinical Research Associate Job Description

Clinical research associates manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs, and procedures. A clinical research associate, also known as a CRA, conducts research to ensure these products are safe to allow on the market.

Clinical Research Associate Job Description Template

We are looking for an organized, flexible clinical research associate to oversee clinical trials. The clinical research associate will develop and outline trial protocols, establish trial sites, train site staff, and manage Investigational Product (IP) and trial materials. The clinical research associate will manage multiple aspects of the subjects' welfare. You will conduct regular site visits, generate and distribute internal and external newsletters, prepare final reports, and liaise with interested parties regarding all trial aspects. You will play a leading role in generating and overseeing documentation and records.

To be successful in this role, you should be able to recognize logistical problems and initiate appropriate solutions. Ideal candidates will be detail-oriented, have the ability to multitask, and be able to collaborate with various role players.

Clinical Research Associate Responsibilities:

  • Creating and writing trial protocols, and presenting these to the steering committee.
  • Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial.
  • Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
  • Liaise with the ethics committee regarding the rights, safety, and well-being of trial subjects.
  • Ordering, tracking, and managing IP and trial materials.
  • Overseeing and documenting IP dispensing inventory, and reconciliation.
  • Protecting subjects’ confidentiality, updating their information, and verifying IP have been dispensed and administered according to protocol.
  • Conducting regular site visits, coordinating project meetings, and writing visit reports.
  • Implementing action plans for sites not meeting expectations.
  • Liaising with regulatory authorities.
  • Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
  • Other tasks and responsibilities as needed.

Clinical Research Associate Requirements:

  • Bachelor’s degree in biological science or a related field.
  • 2+ years of experience as a clinical research associate.
  • Knowledge of the pharmaceutical industry, terminology, and practices.
  • Knowledge of FDA regulations and their practical implementation.
  • Strong verbal and written communication skills.
  • Proficient computer skills.
  • Proficient with Microsoft Office Word, Excel, and PowerPoint.
  • Ability to manage and prioritize workload effectively.
  • Available to travel extensively and on short notice, and ability to manage travel schedules, such as flight schedules.
  • Valid driver’s license, proficient driving skills, own reliable transport, and up-to-date car insurance.

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CCRPS Clinical Research Taininrg

Clinical Research Associate: A Full Guide on Becoming A CRA

clinical research job requirements

Clinical Research Associate

A complete guide on how to become a clinical research associate.

clinical research job requirements

Over 1.9 million students receive a bachelors of science every year. While a few go on to PhD, Masters, and Medical programs; many are ready to start clinical research certification online to start a career in the frontiers of medical research and patient care.

As a new student applying to the science job market, you may only find internships or recognize that even entry-level science jobs requires 1-2 years of experience. More so, you may realize many of these jobs require intense labor in the lab or just did not meet your expectations for your science degree.

This is why a career as a CRA should be considered with clinical research coordinator training. We train over 500 students each month in clinical research coordinator training and clinical research associate training (depending on prior background).

For those who have always wanted a career in medicine or have a gap year before medical school; Clinical Research Training is the next step to getting a head start in your career.

Because the position is unlike actually working in the lab and more of a management role; you get 1-on-1 connections with physicians and medical staff that can lead to a better application for medical school and other medical careers later on.

Best of all; many of these positions accept remote staff (and some allow you to travel 45-75% with full expenses including travel, accommodation, meals, and other per-dime expenses covered).

Clinical Research Training can help you save money while also increasing your salary. CRA’s with our level of training can expect to make between $6,500-$12,000 a month with an estimated promotion rate of 33% a year: an amount that is uncommon in other science-degree careers.

CCRPS is one of the only major US-based ACCRE, ACCME, ANCC, ACPE, and Transcelerate Biopharma accredited CRA certification courses that accepts students with no prior background for certification. T

his is because our course is thorough and created by Senior CRAs who have been in the field for long enough to understand what you need to know to begin working and applying. The course can be completed in as little as 7 days with dedicated full-day study time.

CRA Training

Clinical Research Associate Certification Qualifications

Foreign Doctors Welcome : A Clinical Research Associate or Coordinator plays a vital role in directing and supervising clinical trials conducted by physicians, nurses, and other science professionals. This career path is particularly attractive to many foreign doctors with completed medical degrees (MBBS) who can utilize their expertise in the US healthcare system by pursuing a CRA career instead of taking the USMLE or repeating residency training. For those interested in coordinating aspects, consider the Clinical Research Coordinator course .

Distinct Skillset : Unlike the traditional medical field you may be familiar with after years of schooling, Clinical Research Associate training provides a distinct and valuable skillset. For comprehensive understanding of Good Clinical Practice, see the ICH-GCP course .

Most Extensive Online Course : Our program goes beyond basic introductions, offering a comprehensive curriculum with over 110 modules – the most extensive Clinical Research Associate course available online. This in-depth training ensures you're well-prepared to secure a coveted CRA position.

Superior Coursework : Securing a CRA role is a strategic career move compared to the limitations of many traditional medical positions. While generic courses abound, we've observed that graduates often struggle due to a lack of substantive content. Our Clinical Research Associate course addresses this gap by providing Senior Clinical Research Associate-level training through 110 intensive modules grounded in the latest scientific principles. For those looking to assist in clinical trials, the Clinical Trials Assistant Training may also be of interest.

Diverse Career Opportunities : This high-demand science-based medical field offers diverse opportunities:

Work in the Private Sector : Pursue a CRA career with renowned pharmaceutical companies like Pfizer. Enhance your skills with the Advanced Clinical Research Project Manager Certification .

Academic Opportunities : Work in the academic sphere at medical schools. Those aiming for higher responsibilities may consider the Advanced Principal Investigator Physician Certification .

Unmatched Flexibility and Knowledge : In addition to our exceptional course content, we boast the largest number of clinical research courses available online, providing you with unmatched flexibility and knowledge. For those interested in safety monitoring of drugs, the Pharmacovigilance Certification and Medical Monitor Certification can enhance your capabilities in these critical areas.

Why Take A CRA Certification Course

Growth in CRA pay with experience. Figure courtesy <payscale.com>

 The role of the clinical research associate is to ensure that medical devices, new treatments and new drugs are approved for patients' use.

This field is taken as a certificate program course in many schools. For example, you may find associate degree programs. These programs can be completed in two years and can be offered through both the online and the hybrid formats. Hybrid formats combine both online and on-campus courses together.

If you opt for a fully online program, you can still get an immersive education. Different platforms like emails and discussion boards are used to ensure and promote interaction between the students as well as the lecturers.

Online learning platforms are used to upload the syllabus, course materials, lectures and assignments. Some online programs include field work as part of their requirements, in order for students to gain first hand experience working with clinical trials and patients. Depending on the school, they may have a list of approved clinical research institutes and other facilities. Otherwise, you will have to find a facility for yourself and get the school's approval.

These certificate programs are generally designed for professionals that are already in the medical fields (like medical assistants or nurses) and are interested in moving to the field of clinical research.

They may therefore ask for a copy of your CV or resumé or they may ask for a letter from your employers to verify that you have the needed medical experience. Some programs may require just an undergraduate degree in a medical science or life science related field.

Clinical research associates are trained to assist clinical researchers and investigators in the coordination, administration and management of clinical trials.

During this training, different courses will be taught revolving around subjects like safety procedures, subject recruitment, regulatory requirements, drug development, accountability, trial management, medical terminology etc.

The importance of the role of the clinical research associate means that companies that conduct clinical trials are usually very selective. The need to comply with strict regulations often inform their decision when making a choice of their clinical research associate. It is therefore very difficult to get a job as a clinical research associate without previous experience in clinical trials.

Many companies require around at least two years experience in clinical monitoring as a clinical project assistant or clinical trial administrator before considering applicants for this important role.

In applying for the post of a clinical research associate , ensure that you read the job description and indicate or highlights the relevant experience on your curriculum vitae. Your cover letter should be specific to the company you're applying to.

Do not use a one-for-all cover letter. Personalize your cover letter to each company and highlight the skills that fit the specific requirements of the role. Not all companies advertise their vacancies, so you can try to find out about other unadvertised vacancies, you might increase your chances.

Further certification can enhance your resume such as the ACCRE accredited CRA program which contains 110 learning modules for Clinical Research Associate Training and Placement

The Best CRA Certification Course For Entry-Levels

There is a huge shortage of well-trained CRAs, but many companies are reluctant to hire untrained entry-level clinical monitors because of patient and trial safety. Because of this, even the beginner entry-level jobs require certification or training.

Our program is considered one of the top clinical research graduate programs online. Most courses provide very light training that may look good because of the company names, but alone is not sufficient to pass the interview rounds a company conducts.

Because our modules are prepared help even Senior Clinical Research Associates, we find more of our students with no background quickly passing their interview rounds.

CCRPS Course covers double to triple the amount of course content than other courses. While many courses are simply 5-20 simple interactive modules, our course covers 140 dense modules in thorough detail.

After each session, students can ask their questions privately with the course instructor, all of whom have 15+ years of CRA experience.

Currently, 82% of our students are hired within the first month of taking the course. Students with limited background or those looking to gain extra experience are offered a remote internship of up to 6 months during the time they are interviewing.

This advantage allows many students with limited experience to get hired with a higher paying job than previously offered.

While a majority of our students are physicians, a majority of the CRA workforce are Science Grads and Nurses. nonetheless, we train all students at a Senior CRA level regardless of background because clinical research monitoring is vastly different from any lab or science course you may have taken.

Clinical research associates are given the protocol of a study including all medical protocol that must be followed but because they do not diagnose or treat. Medical knowledge is supplemental but not sufficient in this career path.

This is the main reason why our Clinical Research Training includes all possible scenarios you may face at the protocol and guideline level in your future company.

How To Get Experience For Clinical Research Associate Jobs

CCRPS, like other educational institutes, is only associated with educating and certifying clinical research professionals so we do not provide job placement. We want to make sure you apply with your best foot forward. Below are links we readily refer to graduates who are looking for job support. Having a great CV and cover letter are essential to applying for jobs. Recruiters are paid by the company which hires you and thus are free for searching employees. Be realistic but also be driven. Make sure you get continue reaching out until you get a true rejection from any job you apply to as they may never have seen your application if you received no response.

Clinical Research Job Advising: Kunal at ClinicalTrialPodcast

Free Resume Review: TopCV TopCV provides a free review and feedback for your current resume.

Resume Distribution: ResumeRabbit Resume rabbit distributes your resume to 60 job posting sites.

Clinical Research Recruiters: I-Recruit I-Recruit distributes your resume to clinical research recruiters.

Clinical Research Job Bulletin: Indeed Indeed usually provides the most uptodate job bulletin for clinical research jobs

Always use a cover letter specific for the company and job when applying if you are not using a recruiter.

The ICH-GCP in Clinical Research

Regardless of the type of clinical research or function of an IP being tested, it is important that clinical research should meet two critical criteria:

The clinical research process should respect the rights, freedom and dignity of tested patients (human participants).

Data from the clinical research process should be accurately collected, safely stored, rigorously scrutinized and correctly interpreted.

One way to ensure that these requirements are met is to follow a set of internationally recognized and accepted standards for clinical research. 

Most countries across the world today follow ICH-GCP, that is, International Committee for Harmonization of Good Clinical Practice guidelines in conducting clinical research on human participants7.

The ICH-GCP outlines procedures and precautions that are essential in order to protect the safety and wellbeing of human research participants during clinical research, and to ensure the integrity of data from clinical research studies.

In the USA, clinical studies are required to comply with the FDA Guidance for Good Clinical Practice, outlined in a document titled ‘E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)’8.

In the USA, clinical studies are required to comply with the FDA Guidance for Good Clinical Practice, outlined in a document titled ‘E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)’8.z

Qualifications and Qualities of a CRA

According to the International Accrediting Organization for Clinical Research (IAOCR), candidates for CRA positions usually hold either a biological science degree, or one in medicine or nursing10. 

The New Scientist recommends that aspiring CRAs should possess a good working knowledge of one or more of the following subjects – anatomy, biology, biochemistry, chemistry, immunology, microbiology, pharmacology, physiology or toxicology11.

In addition to a background in medical or life sciences, a CRA is required to have a good grasp of data management, including Electronic Data Capture (EDC), data analytics and reporting12.

Sketching the CRA work profile, the authors Diane St. Germain and Marjorie Good state that CRAs are the ones who scrutinize clinical study data most closely from start to finish—as a result, they are often the first to notice critical patterns and interesting trends, and to report these to the research team as well as to the CRO13.

Equally if not more importantly, a CRA must possess a high level of emotional and interpersonal savvy. This is a crucial area, since a CRA’s success hin ges upon his/her ability to elicit the best from team members, in terms of both performance and probity. 

clinical research job requirements

Core Competency Framework for CRAs

To illustrate, the ACRP’s ‘Core Competency

Framework for Clinical Study Monitoring’

requires that a CRA should be able to identify

and correct compliance violations at a study

site. The CRA must not only bring such

violations to the attention of site staff, s/he

must induce them to take corrective action,

as well as reporting the matter and even

escalating it, where necessary14.

The table below summarizes the ideal

competencies of a CRA, and provides

insights on how each ability contributes to

the CRA’s performance.

CRA Career Path

In the past, CRA positions were often filled by individuals with medical or nursing backgrounds, with little thought given to their lack of research training15. As awareness grew about the importance of research experience for a CRA, employers began preferring those with years of experience in clinical research settings, such as Clinical Trials Assistants (CTAs) and Clinical Research Coordinators (CRCs)16.

However, in recent years, the focus has shifted once again from a tenure-based mindset to a skills-based evaluation17. In part, this change has been brought about by the growth in professional courses and training programs in the field. 

For instance, many leading US Universities today offer master’s programs in clinical research18. In addition, there are some widely recognized certification programs for clinical research associates, such as those offered by the ACRP19 and the Society of Clinical Research Associates (SOCRA) 20.

Note: You must already be working as a CRA to qualify for the ACRP and SOCRA certification programs.

A Toe in the Door: CRA Certification for a Non-CRA

By this point, you might be wondering, “I have no research experience… I’ve never worked as a Clinical Trials Assistant (CTA) or a s a Clinical Research Coordinator (CRC). Nor do I have a degree in Clinical Research. Can I still become a CRA?”

The simple answer is, yes, you can.

You might be a life sciences graduate looking for a lucrative career in the pharmaceutical or biotechnology sectors. Or, you’re excited by a career in research, but unsure whether the drudgery of a Ph.D. is your thing.

Maybe you’re just looking for a job that represents a great option for someone with your combo of science background plus detail-orientedness.

Whichever of these descriptions best applies to you, a career as a Clinical Research Associate could be exactly right for you.

With the right training, you can be recruited directly to a Clinical Research Associate position, even without a background in clinical research.

So, what kind of training will help me break through the ‘experience’ barrier and land a job as a CRA?

As you’ve already gathered from the table, the skill-set required to be a successful CRA is pretty extensive.

Aside from an in-depth knowledge of scientific and medical concepts and principles, a CRA must have a sound grasp of medical research regulatory requirements, a penchant for being thorough and systematic, as well as a knack for coordinating and managing people with diverse skills, roles and backgrounds.

To our knowledge, CCRPC’s ‘Advanced Clinical Research Associate Certification’ (ACRAC) is one of a kind: The ACRAC is the only multi-accredited* certification program in the US that offers the kind of exhaustive as well as intensive training that equips candidates from a non-clinical background with the abilities and competencies that make a good CRA.

Best of all? The ACRAC is open to fresh graduates holding a B.S. degree in any of the life sciences, with no requirement for prior exposure or experience in clinical research.

*The ACRAC program offered by CCRPC is accredited to ACCRE (Accreditation Council for Clinical Research & Education), ACCME (Accreditation Council for Continuing Medical Education), ACPE (Accreditation Council for Pharmacy Education), ANCC (A merican Nurses Credentialing Center), as well as Transcelerate Biopharma.

becoming a cra

Training to be a CRA through CCRPS ACRAC

The ACRAC program includes over 100 course modules that cover all the important knowledge domains and skill-sets required by a CRA.

Designed for a total study time of approximately 250 hours, this training program can be completed at your own pace, or, for those able to dedicate the whole day to study, in as little as two to three weeks.

Starting with a broad overview of clinical research jargon and terminology, the course walks students through the principles of Good Clinical Practice, familiarizing you with the relevant sections of the ICH-GCP and the FDA’s E6(R2).

The program places particular emphasis on ethical practices in research with vulnerable populations.

Students going through the ACRAC are trained in all major aspects of designing a Clinical Trial Protocol in keeping with the Code of Federal Regulations (CFR).

They additionally learn the steps involved in the IRB/IEC approvals process and how to prepare required documents.

Finally, students become aware of the importance of pharmacovigilance and the regulatory process for new drug testing.

A major chunk of the ACRAC certification centers around equipping the CRA for day-to-day responsibilities, such as different types of site visits – preliminary (Site Qualification), preparatory (Site Initiation) and progress monitoring visits (Routine Monitoring).

Crucially, the ACRAC covers essential documentation such as the Case Report Form and Trial Master File, as well as electronic data capture (EDC) and remote monitoring systems.

A vital component of the training program involves empowering students to tackle challenging situations.

For a CRA, these include identifying protocol deviations and violations, and recognizing as well as reporting research fraud and ethical misconduct.

In addition to its comprehensive coverage, the ACRAC certification offers the great advantage of including 17.5 CME credits – that is, course credits that count towards ‘Continuing Medical Education’.

These credits can be used by individuals desiring to further their education and/or careers in healthcare-related fields, including medicine, nursing, pharmacy and research.

clinical research job requirements

Clinical Research Associate Training

Get ahead in clinical research with advanced accredited online CRA certification for $450. Demo our on-demand course below.

Clinical Research Associate Certification

Advanced clinical research associate certification (acrac).

Chapter 1: Introduction

This chapter orients you to the concept of Continuing Medical Education (CME) and outlines how the CCRPS CRA program contents meets AMA requirements for CME. Given that, across the US, physician practitioners are required to complete between 20 and 50 hours of CME credits yearly, the ACCME-accredited CCRPS CRA course can be used not only to build knowledge and skills in the field of clinical trial management, but also to further a successful medical career. Additionally, the introductory chapter introduces you to the clinical terminology and abbreviations commonly encountered in clinical research, for example, Investigational Product (IP), Good Clinical Practice (GCP), Institutional Review Board (IRB) and so on. 

Chapter 2: Roles and Relationships in Clinical Trials

The unit presents the foundational background to beginning and building a career as a clinical research associate (CRA). As you know, a CRA plays a critical role in setting up as well as monitoring the clinical trials process for an investigational product or IP – a medical drug or device under development. In this unit, you will learn how a CRA interacts with other stakeholders, including the Clinical Research Organization (CRO) or Sponsor of the clinical trials, the Principal Investigator (PI) as well as other research site staff, the trials monitoring team including the Clinical Research Coordinator (CRC),other CRAs and the Data Safety Monitoring Board (DSMB), as well as the research ethics committee (Institutional Review Board or IRB).

Chapter 3: Sponsor and Investigator Roles

In this unit, you will gain insight into the ICH-GCP guidelines, particularly addendum E6, sections 2 through 5, which outline procedures and precautions essential for protecting the safety and wellbeing of human research participants during clinical research. These include guidelines for obtaining informed consent from human subjects, maintenance of trial records, reporting of compliance, safety and research progress, as well as procedures for suspension or termination of the trials process. The chapter familiarizes you with the critical importance of monitoring for Adverse Events (AEs), including types of AEs and regulations for documentation and reporting.

Chapter 4: Clinical Trial Design

In this chapter, you will acquire insight into the different phases of the clinical trials process, from the pre-clinical phase through Phases 0 to 4 of clinical testing. The unit will familiarize you with important concepts of clinical trials, such as the structure and goals of each phase of clinical trials, approaches to dosing, toxicology of pharmaceutical products, in vitro and in vivo testing, dose escalation and so on. Finally, the chapter reviews the FDA’s drug approval process.

Chapter 5: ICH-GCP – Overview

The chapter dives deep into GCP, including a review of the history of medical research leading up to the ICH-GCP. The unit covers all four QSEM categories of the guidelines for ensuring Quality, Safety and Efficacy of the IP, as well as  Multidisciplinary guidelines (mainly pertaining to documentation and electronic data safety standards). In addition, the chapter includes an overview of MedDRA software that provides a standardized system of terminology and notation for documenting clinical research, as well as principles of budgeting for clinical trials.

Chapter 6: Ethical Research in Vulnerable Populations

The unit provides a detailed walk-through of the regulations and compliance requirements for conducting clinical trials with human subjects who meet the definition of a ‘vulnerable population’, including pregnant women and fetuses, children, mentally incapacitated individuals (those with cognitive functioning impaired by neurolopsychological conditions or chronic substance abuse), as well as prisoners. You will acquire familiarity with the challenges of research in such populations, including the requirement for parental consent, fair but not excessive incentive, justifiable deception or incomplete disclosure, coercive practices and so forth.

Chapter 7: Adverse Events

Through this module, you will gain a bird’s eye view of the protocol for documenting, reporting and responding to AEs or adverse events during the clinical trials process. The unit covers concepts such as expectedness, severity and seriousness of AEs, Adverse Drug Reactions (ADRs) as a sub-category of AEs, Investigational New Drug or IND reports, causality analysis for AEs and so on. In addition, the chapter reviews the responsibilities of both research sponsors as well as IRBs in sharing AE information with subjects. 

Chapter 8: Clinical Trial Protocol

The chapter provides an in-depth tutorial on the structure and elements of a CTP or clinical trial protocol, as well as guidelines on writing a CTP. Important concepts reviewed include study Risk Benefit Analysis (RBA), study sample statistics (sample size, statistical power, plan for data analysis), risk management and study administration. Additionally, the module covers concepts central to study sample selection, addressing inclusion and exclusion criteria, especially safety and ethics considerations in sampling. 

Chapter 9: Protocol Deviations and Violations

Through this unit, you will gain familiarity with the many potential causes of protocol deviations and violations, learning to distinguish between minor (deviations) and major departures or violations of protocol. Content provides understanding of the most commonly occurring violations, including both minor (off-schedule subject assessments, subjects’ use of prohibited drugs, and so on) as well as major violations (failure to obtain informed consent, failure to report AEs and so forth). Further, the chapter reviews principles for reporting protocol deviations, IRB approval for planned deviations and related concepts. 

Chapter 10: IRB and DSMB

This chapter briefly reviews the history of IRBs and examines the principles guiding IRB decision-making. In addition, the unit discusses recent developments in compliance, including sIRB (single IRB) and SmartIRB for institutions that are part of the CTSA (Clinical and Translational Science Awards). The bulk of this module dives into the categories of IRB review, including full board and expedited review, examining criteria for review exemption such as educational or purely behavioral research, as well as studies collecting identifiable data, surveys and interviews.   

Chapter 11: Review Questions

The module provides a self-assessment tool by including questions that review the content covered in previous chapters. The set of 71 questions examines all aspects of ICH-GCP previously discussed.

Chapter 12: Site Monitoring Visits

In this module, an overview is provided of the different types of site monitoring visits, including site selection or qualification visit, study initiation visit, routine or progress monitoring visit, as well as study termination or close-out visit. Important concepts discussed include pre-qualification preparations and site feasibility assessment as well as study monitoring criteria (data omission, incorrect entries, inaccurate calculations, documentation of corrections and so on). For each type of site monitoring visit, the chapter reviews relevant documentation.

Chapter 13: Site Qualification Visit (SQV)

The chapter gives an in-depth understanding of the stages and steps involved in selecting a study site. Elements reviewed within the module include the process of investigator selection and criteria for site evaluation (the four P’s: Patient, Protocol, Performance, Profit). Importantly, the module reviews the most common errors in feasibility assessment, including overestimation of sample availability at site, selection of site staff with low motivation, poor-performing sites owing to high competition for personnel and resources (for example, owing to multiple studies running on a single site), and so on.  

Chapter 14: Site Initiation Visit (SIV)

The module dives into the details of an SIV or site initiation visit. You will review the procedure for pre-SIV preparation, including filing for IRB and other necessary approvals, permits and licenses. Additionally, the chapter examines elements of the SIV agenda, mainly orientation and training of site staff, creation of important study-related documents such as the Trial Master File (TMF) and post-SIV filing of compliance documents such as FDA form 1572 and Financial Disclosure Form (FDF) for relevant site personnel. 

Chapter 15: Routine Monitoring Visit (RMV)

In this unit, the elements of a routine or periodic monitoring visit are discussed in detail. You will become familiar with the agenda of an RMV, which prioritizes receiving updates on AEs from site staff (incidence, documentation, seriousness and so on), as well as oversight of the overall progress of trials. The chapter covers different approaches to site monitoring, contrasting traditional (full-scale) monitoring with risk-based monitoring (RBM), as well as comparing on-site monitoring with remote monitoring. A crucial concept addressed by the unit is Source Data Verification (SDV), which is central to obtaining meaningful, high-quality data from clinical trials.

Chapter 16: Site Close-Out Visit (SCOV)

The module gives you a comprehensive overview of the protocol and procedures involved in terminating or closing out a trial site. Aspects covered in the chapter include pre-SCOV preparations such as IRB notification and schedule coordination among site staff (PI, other investigators, medical staff) and monitoring team (CRC, CRAs and so on), agenda for an SCOV – drug inventory management, database verification and lockdown, subject intimation and completion of all subject-related documents, staff-related documentation as well as other administrative tasks including close-out report compilation.

Chapter 17: Tools for Monitoring Visits

This unit outlines a host of tips and tools that can help a CRA in successfully tackling the complex process of monitoring clinical trials. The chapter lists numerous physical accessories you can use for effective monitoring, including scheduling and calculation aids, ready reckoners for drug information and medical terminology, as well as document templates to speed up the process of obtaining trial updates while also serving as checklists for the site visit agenda. Additionally, the unit highlights helpful strategies that a CRA can use to ensure that site visits go smoothly, from travel advice to team-building suggestions. 

Chapter 18: Audit and Inspections

The module deals with one of the most crucial and often most feared aspects of a CRA’s career – audits and inspections by the CRO (sponsor), FDA or other regulatory authority. Starting from the basic distinction between an audit and an inspection, the chapter covers in detail the protocols for both audits and inspections. Crucially, the chapter will enable you to grasp the difference between a routine audit/ inspection and a ‘for-cause’ audit/ inspection. Further, it lays out the sequence of an FDA inspection in full (including a detailed walk-through of the FDA BIMO or Biomedical Research Monitoring Program inspection), and provides important guidelines on the do’s and dont’s for CRAs during an audit/ inspection, such as the critical ‘3 to 5 minute rule’. You will acquire familiarity with important audit and inspection-related documents such as FDA Form 482 (Notice of Inspection) and Form 483 (Notice of Observation) as well as the Establishment Inspection Report (EIR) prepared by the auditor/ inspector. Finally, you will gain insight into the classes of observations provided in an EIR, including NAI (no action indicated), VAI (voluntary action indicated) and OAI (official action indicated)—the last is commonly termed an ‘FDA warning letter’.

Chapter 19: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, as well as a 15-item quiz. Questions and quiz examine all aspects of clinical trial quality monitoring, including monitoring visits, tools as well as audits and inspections.

Chapter 20: SDV and Informed Consent

In this chapter, the ICH-GCP section 4.8 guidelines on obtaining informed consent from subjects are discussed in detail, highlighting the need for using non-technical language, transparent delineation of risks, consent without undue influence, obtaining consent (and assent) from minors and their Legally Acceptable Representatives (LARs), as well as consent from non-English speakers and sedated subjects. The chapter additionally covers important aspects of Source Data Verification (SDV) with respect to electronic as well as paper-based medical records, and highlights the central goal of SDV, which is to conform to ICH-GCP requirements that subject trial data (as recorded in Case Report Forms or CRFs) must correspond to source data (previous medical records).

Chapter 21: Case Report Form

The module provides an in-depth tutorial on the structure and elements of a Case Report Form or CRF, including the different forms for PI verification, subject enrollment, eligibility and randomization, medical history, physical examination and laboratory data, compliance, adverse events and so on. In addition, the chapter outlines important data notation rules, such as the use of accepted acronyms (‘ND’ for missing data and ‘UNK’ for unknown information, MM-DD-YY format, time-stamp data and so forth), as well as guidelines for the design of CRFs (such as consistency of notation, avoidance of data fields that can be computed and of duplicate data fields and so on).

Chapter 22: Quality Control and Safety

Within this unit, you will learn the central concepts of Quality Control (QC) in the context of clinical trials, including definitions of QC and its relationship with the complementary process of Quality Assurance (QA), the use of Key Performance Indicators (KPIs) in QC, need for a Corrective and Preventive Action (CAPA) plan and so on. Additionally, the module examines the QA process, focusing on the central role of RBM or risk-based monitoring in present-day QA as well as providing guidelines on Quality Metrics (QMs) for evaluating the trials process. The chapter also reviews ICH-GCP guidelines on subject safety, underlining risk-benefit assessment, stoppage rules (for instance, in case of SAEs) and reporting responsibilities. Finally, it introduces the FDA’s Human Research Protection Program (HRPP) as a platform that provides training and support for personnel involved in clinical trials.

Chapter 23: Technology in Trials

In this chapter, an in-depth tutorial is provided of the systems used in modern clinical trials for Electronic Data Capture (EDC) and database management. Systems such as Interactive Response Technologies (IRTs) including IVRS and IWRS (Interactive Voice and Web Response Systems, respectively) as well as RTSM systems for Randomization and Trial Supply Management are examined.  The unit reviews the benefits of standardized data management and data sharing, approaches to database management and the concept of an Independent Data Monitoring Committee (IDMC). Critical elements of data integrity, such as proper anonymisation and coding, completeness of data, data safety precautions and logging of site visits and other progress reports are highlighted. The unit further examines the essential features of a good Clinical Data Management (CDM) system that complies with FDA CFR Title 21 and HIPAA regulations, such as setting access privileges, tracking changes and updates, data security and locking, flagging and reconciliation of AEs and so forth. Finally, the chapter looks at CTMSs (Clinical Trial Management Systems) in depth, covering the aspects that allow management of day-to-day trials in multi-site studies. 

Chapter 24: Modernized Monitoring (Remote, Risk-based, Centralized)

 This chapter offers a detailed walk-through of modern, remote monitoring of clinical trials, which evolved into a full-fledged system in response to the COVID-19 pandemic. Important concepts discussed include the critical site initiation process, Electronic Source Data Verification (ESDV) and FDA regulatory guidance for remote monitoring of clinical trials. In this module, you will learn how FDA’s ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) criteria for data quality have been adapted to remote monitoring. Further, the unit discusses how HIPAA compliance in remote monitoring is achieved by using limited data sets (wherein sensitive individual information is concealed through anonymous subject codes) regulated by data use agreements. Finally, the unit examines how risk-based monitoring approaches have allowed centralized monitoring to evolve into a cost-effective and safe method for clinical trial monitoring.

Chapter 25: Pharmacovigilance and Regulatory Affairs

Through this unit, you will gain insight into the process and rationale behind pharmacovigilance (PV) and its central role in the clinical trials process. The chapter reviews the statistics on AEs, distinguishes between Type A and Type B AEs, and profiles seriousness of ADRs or Adverse Drug Reactions as well as the iGuard Drug Risk Rating System. Importantly, the unit covers ADR causality assessment in detail, including both severity and probability assessment. An important element of PV addressed in this module is the Individual Case Safety Report (ICSR), its structure, content and role in trial monitoring. Other concepts discussed include types of PV inspections (routine vs. ‘for cause’), PSURs or Periodic Safety Update Reports and study criteria for instituting DSMBs (Data Safety Management Boards). Finally, the module also reviews the domain of Regulatory Affairs (RA) as a function of PV, outlining roles and responsibilities of RA personnel as well as the importance of RA in streamlining the process of drug development by ensuring compliance throughout manufacturing, clinical trials, marketing and advertising.

Chapter 26: Investigational Product

In this chapter, an in-depth review is provided of the protocol for receiving, storing and dispensing the IP or investigational product. At every stage, guidelines lay down strategies for ensuring verifiability, accountability and safety of both study subjects and staff. Thus, IP handling precautions include the need for logging date of manufacture, temperature throughout transit, as well as batch number and individual unit numbers (such as bottle or tube identifiers) carefully and accurately, as well as recording shipping details and filing shipping receipts. Additionally, the unit addresses the need for IP dispensing precautions, such as limiting dispensation to authorized personnel only, as well as maintaining individual subject IP logs.

Chapter 27: Local and Central Labs

The module profiles the evolution of lab testing in clinical trials, from error-prone localized laboratory testing to centralized testing that allows homogeneity of testing procedures and measurements, thus minimizing errors and improving outcomes. The chapter reviews standards for clinical trial laboratories as per the GLCP (Good Clinical Laboratory Practice) and CLIA norms (Clinical Laboratory Improvement Amendments), as well as providing guidelines for lab audits, including fire safety, protective gear, staff training and so forth.

Chapter 28: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, as well as a 15-item quiz. Questions and quiz examine all aspects of trial documentation (SDV, CRF, ICSR), quality control, pharmacovigilance, as well as IP and lab guidelines.

Chapter 29: Regulatory Documents in Clinical Trials

The chapter reviews essential documentation to be created and maintained throughout the course of the clinical trials, including the Trial Master File (TMF), FDA forms 1571, 1572, 3674, 3454/3455 and CFR Title 21 Form 312, besides ethics approval documents such as the IRB-approved protocol, informed consent form, subject education and study advertising materials. You will acquire in-depth familiarity with each of these forms, and learn the importance of maintaining and updating records, for example by incorporating IRB revisions and amendments, periodic renewals of permissions and licenses and copies of submitted reports. In addition, the unit summarizes the need for filing documents outlining study- and site-specific procedures, including SOP (Standard Operating Procedure), MOP (Manual of Procedures), Investigator Brochure (IB), Delegation of Authority Log (DOAL), site staff CVs, SAE notifications, logs of subject screening and enrollment, IP storage (temperature, humidity, etc.) and all relevant study parameters.

Chapter 30: CFR Title 21 Part 11 – Electronic Signatures

This unit gives you an overview of Title 21 of the FDA Code of Federal Regulations (CFR), including Chapter 1 sections on informed consent (Section 50), IRB approval (Section 56) and so on, Series on food (100), pharmaceuticals (200 and 300) and so on, as well as FDA Drug Schedules. The major part of the module focuses on Part 11 which deals with Electronic Records and Electronic Signatures (ERES), laying down the criteria for determining safety and reliability (trustworthiness) of electronic data and signatures.

Chapter 31: New Drug Application

Through this module, you will gain knowledge of the FDA process for evaluating a drug under development, and the role of a CRA in streamlining this process. An important distinction covered here is the difference between an IND (Investigational New Drug) and an NDA (New Drug Application). The chapter discusses in-depth the criteria used in evaluating an IND, including toxicology and pharmacokinetics data, as well as requirements for different drug classes (oncology vs. non-oncology). Additionally, the unit covers FDA requirements for AE reporting, including assessment of seriousness, expectedness and format for expedited reporting of life-threatening SARs, as well as safety reporting requirements for investigators. 

Chapter 32: Trial Master File

The unit provides a detailed breakdown of the organization of a TMF or Trial Master File, listing the various binders that should be included within the TMF, as well as their contents. Thus, the TMF should contain binders pertaining to the study protocol and IRB, investigator qualifications, FDA forms and correspondence, FDFs or Financial Disclosure Forms, communications with the CRO, and other relevant trial aspects. A helpful templatic guide to creating a TMF is also provided in this chapter, as well as a self-assessment quiz of 10 items on important sections of a TMF. 

Chapter 33: Disclosures and Payments for PI, Site, Patients

In this chapter, FDA guidelines regulating financial disclosure are discussed in-depth, covering the definition of ‘conflict of interest’ and the stipulations of Title 21 Section 54 on disclosure requirements. The unit helpfully contrasts FDA requirements with Canadian and UK/EU policies. You will study real life case examples of conflict of interest, as well as lawsuits pertaining to financial disclosure disputes to help gain a better understanding of the potential problems arising from failure to disclose financial interests in clinical trials. Another important dimension covered in the module is the regulation of payments to PIs and other investigators as well as patient payments, which must comply with CMS (Center for Medicare and Medicaid Services) policy on ‘fair market value’ as well as the Federal ‘Anti-Kickback Statute’. The unit contains guidelines on clinical trial budgeting and subject payments. Finally, the chapter reviews IRB guidelines on advertising to recruit human participants for clinical trials, including stipulations against misleading and coercive language, as well as excessive incentives.

Chapter 34: Patient Recruitment, Retention and Compliance

The unit provides an overview of the process of patient (subject) recruitment in clinical trials, from population research to identify motives for participation, to media support for building up public awareness and interest, to community and physician outreach for referrals and enrollment. Additionally, the chapter identifies common barriers to meeting recruitment goals and outlines strategies for maximizing recruitment, such as relaxing overly stringent criteria, offering reasonable incentives such as travel reimbursement and highlighting benefits of participation. Similarly, the unit covers common causes of patient drop-out as well as strategies for minimizing drop-outs, such as improving patient experience (increased attention and listening to patients, flexible scheduling of visits to suit patients’ convenience and so on). Finally, the unit discusses novel strategies to increase patient retention and improve compliance in clinical trials; these techniques harness technology to yield better outcomes, for example, simplifying form completion through digitized forms with auto-fill features, gamifying elements of compliance reporting, and so forth.

Chapter 35: Misconduct and Fraud

This module discusses the various motives for committing scientific fraud and the fallout of fraudulent practices in clinical trials. A scale for classifying errors in clinical trial data is presented, with ‘honest, isolated mistake’ at one end of the spectrum and ‘deliberate data falsification with malicious intent’ at the other. Types of clinical data that may be falsified, methods used in falsification (fabrication, substitution, omission), as well as scenarios in clinical trials where falsification may be occurring are presented. Through this chapter, you will gain familiarity with the signs to watch out for during the actual clinical trials process. 

Chapter 36: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, including questions on all aspects of regulatory documents, site documents (TMF and contents), trial budgeting and payments, patient recruitment and scientific fraud.

Chapter 37: Site Visit Templates 

This module contains a set of templates that you can use for documenting the details of site monitoring as a CRA, either in their current form, or in a form adapted to the needs of your own study. The templates included in this unit include:

Site Qualification Visit (SQV) – checklist for preparations, questionnaire for assessing the site prior to the actual visit, assessment form and follow-up letter

Site Initiation Visit (SIV) – agenda for visit, confirmation letter to request PI attendance during SIV, report following SIV

Routine Monitoring Visit (RMV) – confirmation letter to request PI attendance, report following RMV, follow-up letter

Site Close-Out Visit (SCOV)  – confirmation letter to request PI attendance, agenda for SCOV, report following SCOV, follow-up letter

CRA transition letter  – document notifying site PI of appointment of new monitor (yourself as CRA) 

Chapter 38: Interviewing and Career

In this unit, you will find suggestions and recommendations for making a positive impact in interviews for CRA positions, as well as tips and strategies for making rapid progress in a clinical research career.

Chapter 39: Final Examination

This module comprises a comprehensive 51-item, self-paced quiz to assess your competency in the skills and knowledge required for a Clinical Research Associate position. 

https://www.beroeinc.com/category-intelligence/clinical-research-organizations-market/

https://www.linkedin.com/jobs/search?keywords=Clinical%20Research%20Associate&location=United%20States&geoId=103644278&trk=public_jobs_jobs-search-bar_search-submit&position=1&pageNum=0

https://www.centerwatch.com/articles/24791-demand-for-experienced-clinical-trial-professionals-outpacing-supply-acrp-says

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3317309/

https://www.niaid.nih.gov/research/dmid-investigational-product

https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research

Dixon JR. 1999. The international conference on harmonization good clinical practice guideline. Quality Assurance. 6(2): 65-74. DOI: 10.1080/105294199277860

https://www.fda.gov/files/drugs/published/E6%28R2%29-Good-Clinical-Practice--Integrated-Addendum-to-ICH-E6%28R1%29.pdf

https://www.who.int/groups/research-ethics-review-committee/recommended-format-for-a-research-protocol/

https://iaocr.com/finding-first-clinical-research-job/

https://jobs.newscientist.com/en-au/article/a-career-in-clinical-research/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326906/

St. Germain DC, Good MJ. 2017. Data management in clinical trials. In: Gallin JI, Ognibene FP, Lee Johnson L, editors. Principles and practice of clinical research. San Diego: Academic Press. p. 531-545. ISBN 978-0-12-849905-4

https://acrpnet.org/wp-content/uploads/dlm_uploads/2017/04/clinical-study-monitoring-competencies.pdf

https://www.clinicalleader.com/doc/starting-a-career-in-clinical-research-things-we-wish-we-knew-0001

https://www.proclinical.com/blogs/2021-9/how-to-get-a-job-as-a-clinical-research-associate-cra

https://acrpnet.org/2018/06/11/5-clinical-research-trends-emerge-at-acrp-2018/

https://www.collegechoice.net/sciences/clinical-research/best-masters-degrees/

https://acrpnet.org/certifications/cra-certification/

https://www.socra.org/certification/program-overview/

Pharmacovigilance: A Complete Guide to Pharmacovigilance and Drug Safety Training

The ultimate guide to clinical research monitoring.

7 Strategies for Getting an Entry-Level Clinical Research Job

News December 8, 2020

clinical research job requirements

Kunal Sampat, MNA, ACRP-CP, Host of the Clinical Trial Podcast

Many people applying for entry-level clinical research jobs may begin their journey by enrolling in a certificate program. They invest months or years, not to mention thousands of dollars, toward earning a certificate, yet upon finishing and hitting the job markets, are likely to still be dealing with unresponsive hiring managers who are looking for individuals with two years of experience. (It is important to note here that having a “certificate” in clinical research from some source is not the same as holding “certification” in clinical research—an achievement based on mastery of job roles and solid experience in the field.)

How does one get around such a situation to get that first dream job in clinical research with less hassle, less expense, and more reliable prospects for employment at the end of the process? Presented here are some strategies that can work extremely well for individuals with foreign medical degrees, backgrounds in life sciences or allied health, or experience working in a regulated environment.

1—Gain clarity on your career goals.

  When most people apply for clinical research jobs, they fire up their computer and start applying for open positions. Before applying you should begin your journey by answering the following questions:

  • Do you want a paid job or a volunteer opportunity? Is the experience you’ll gain more important, or do you really need a paycheck right away?
  • Who do you want to work for? Clinical research is a vast field with different types of companies offering different kinds of job opportunities. You can work for a contract research organization, a sponsor such as pharmaceutical or device company, a clinical research vendor, a regulatory authority such as the U.S. Food and Drug Administration , a nonprofit organization such as a patient advocacy group, an institutional review board, or a study site, to name some of the options.
  • What job role are you most interested in? Is there a specific one you’d enjoy more than others? There are many other clinical research opportunities in addition to the clinical research associate (CRA) or clinical research coordinator (CRC) roles. For example, you can work as a data manager, safety monitor, patient recruiter, medical writer, biostatistician, project manager, regulatory compliance manager, or research billing expert.
  • Would you enjoy working in the field (traveling or remote work) or in an office environment? Some people enjoy being on the road (and earning frequent flyer points). Others get more energy interacting with people at the office. Most clinical research roles offer the ability to work remotely or in an office setting.
  • Are you open to relocating to a different city, state, or country? Entry-level positions may not offer the best pay, so you’ll need to decide if you’d be open to relocating, even if the pay was low.
  • Are you looking for full-time, part-time, or contract employment? Depending on your personal circumstances, you may be more interested in a full-time position for the medical benefits or in a part-time role for a better work-life balance. Alternatively, you may be interested to contract opportunities at first and then transition into full-time employment once you have experience under your belt.

Answering these six questions honestly will give you the necessary clarity on which opportunities you should pursue and which ones you shouldn’t.

2—Invest in your clinical research education.

At a minimum, I encourage everyone to become familiar with the tenets of Good Clinical Practice (GCP) early in their job quest. Depending on the type of clinical research organization you decide to work at, your training beyond GCP will differ significantly. For example, training for an oncology pharmaceutical company will be different than training for a cardiology medical device company.

You can watch hundreds of YouTube videos on clinical trials or medical technologies, attend conferences or seminars, and get in-depth software training, but still not have a job in clinical research. Here is what you can do to narrow down your clinical research education priorities:

  • Identify the dream role (career opportunity) you’re interested in applying for.
  • Read through the job description—specifically, the job requirements.
  • Highlight the skills you have little or no knowledge or experience with.
  • Look up webinars, YouTube videos, and literature to develop those specific skills (i.e., fill the skill gap).

The above plan won’t make you an expert in those skills, but you will have built confidence in yourself and your ability to speak to these topics during interviews. If you feel you need more training, I encourage you to sign-up for membership with nonprofit professional organizations such as ACRP or SOCRA . Membership gives you access to many training resources; a lot of information is available to you for no additional cost aside from the basic membership fee.

Additionally, with your membership, you end up surrounding yourself with other experienced clinical research professionals via networking with their virtual communities and by attending educational events. You can then reach out to your fellow members for career guidance and make them aware of your interest in working in clinical research.

3—Fix your resume.

Your resume must not read like a job description. Most employers rely on a resume to screen applicants. Unfortunately, if your resume reads like a job description, the hiring manager does not get a clear understanding of your contributions in your current and previous roles. Instead, your resume should reflect your own professional achievements. You want to clearly state the results you achieved in your previous roles and, when possible, you should quantify the results. For example, instead of stating, “Worked in a research lab analyzing preclinical data,” you might want to state, “Analyzed data from two preclinical studies in mice for an Alzheimer’s drug.”

If you feel like your clinical or medical-oriented experiences are limited, focus on transferable skills for the research position you seek. Transferable skills such as financial management, project management, writing, and informational systems management are applicable to clinical research as well.

 4—Focus on 10 job opportunities and always follow up.

Focus on only 10 job applications at a given time. Many applicants apply for multiple jobs every week during their searches. Over the course of a couple of months, they have applied for dozens of jobs, but probably haven’t had a formal interview for any position. Instead of applying for every possible clinical research job as soon as they appear on the radar, I have found that applying for 10 at a given time gives applicants the time and energy to personalize their approach for each position.

Following up with employers is absolutely necessary. Even though hiring is a top priority for many organizations, hiring managers get busy with their day-to-day activities and hiring can take the back seat. By following up with the hiring manager, you’re demonstrating your continued interest in working for the company.

5—Write and speak clearly.

Aside from strong technical skills for many jobs, you may also need to demonstrate above-average written and verbal skills. This is important because clinical research is a cross-functional, team-oriented field. For most roles, you’ll be working in a team environment. When the job description states, “candidate must have excellent communication skills,” the employer wants to ensure you can write and speak clearly.

Many candidates will create a page-long, generic cover letter that repeats everything that can be found in their resume. Such a cover letter fails to show the employer why you’re the right fit for the role. Instead, I recommend applicants write a cover letter with three to five bulleted points that outline the benefits of hiring him or her for the job. The more personalized your cover letter is to a given employer and role, the greater chance you have for being invited for an interview.

Personalized cover letters might make reference to a specific clinical trial the hiring company is running, the company’s therapeutic area(s), and other details that show you’ve done your homework and are engaged in the opportunity to work there.

When it comes to verbal communication, the easiest way to have clarity in your message is to write down the key points you want to discuss on the phone. This forces you to be clear about why the company should hire you and not some other candidate with equivalent credentials.

6—Prepare for your interview.

Once you’ve landed with an interview date, it is time to prepare for the interview, using the following tips:

  • Read the “About” and “News” section of the company website. Learn about the company’s clinical and regulatory leadership team. The news section will provide insights from the latest press releases from the company. This will give you an idea of what is on the company’s “mind.” You can also visit ClinicalTrials.gov for more information on the company’s trials, and to get a better understanding of the medical treatments being developed and their targeted patient populations.
  • The biggest unknown in any interview is that you do not know what questions the interviewer will ask you. To help focus your answers, I recommend that you come up with a list of five to eight examples from your education or professional experiences that you’re proud of or that taught you something valuable. When possible, limit these to experiences that are medical or clinical in nature. Next you want to create a story around each of these examples that will become a valuable answer to an appropriate question. The best way to create a story is using the STAR format (Situation, Task, Action, and Results). For each of these examples, you want to write down the situation, the task in front of you, the action you took, and the results achieved as a result of your actions.

Once you’ve completed these steps, you’re almost ready for the interview. The last thing you need to do is to appear and sound professional during and after the interview. Be sure you write a personalized “thank you” note after each interview.

7—Have the courage to hear “No.” Remember that you will eventually hear “Yes.”

Many entry-level clinical research applicants lack the courage to hear that, “No, we cannot hire you for this job” from potential employers. It is painful to hear a “No” and rightfully so. Furthermore, most employers do a poor job of providing constructive feedback to applicants they don’t want to hire. Employers don’t want to say “No” to the not-so-great candidates because they fear not finding the “right” candidate for the job; they prefer to have a backup list of candidates in case their preferred candidate doesn’t work out.

This makes it even more important for candidates to encourage employers to make a decision, whether it’s a “Yes” or a “No.” This not only helps the candidate, it also helps employers to move on to other candidates who might be a better fit for the organization.

You don’t need to sign up for an expensive and time-intensive clinical research certificate program to secure an entry-level job in clinical research. Instead, you need to gain clarity around your clinical research career ambitions, learn GCP, invest in your continued education through nonprofits such as ACRP and SOCRA, fix your resume so that it doesn’t read like a job description, focus on 10 open opportunities at a given time, write and speak clearly in all your communications with the potential employer, plan for your interview using the Situation, Task, Action, Results (STAR) format, and embrace rejection if you’re not hired for the role. These strategies, collectively, will increase the odds of your success tremendously and you’ll be on your way to experiencing the joys of working in clinical research and clinical trial management.

by Guest Contributor Kunal Sampat, MNA, ACRP-CP, Host of the Clinical Trial Podcast

BEAVER Method—How to Get a Job in Clinical Research

Navigating a Career as a Clinical Research Professional: Where to Begin?

Getting Started in Clinical Research

How to Enter the Clinical Research Field

Who’s Who in Clinical Research

Introduction to Good Clinical Practice

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Clinical Research Associate

Primary responsibilities.

  • Participates in the investigator recruitment process and performs site qualification visits of potential investigators.
  • Evaluates the capability of the site to successfully manage and conduct the clinical study.
  • Collaborates with the start-up department to coordinate activities with the site in preparation for the initiation of the study.
  • Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials.
  • Works with start-up, project team and site staff to obtain regulatory (IRB/IEC) approval of study specific documents.
  • Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF, monitoring activities and study close-out activities.
  • Trains site staff on the EDC system and verifies site computer system.
  • Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.
  • Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits.
  • Performs validation of source documentation as required by sponsor and prepares monitoring reports and letters per the timelines defined in RQM+ SOPs by using approved templates and reports.
  • Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor.
  • Performs investigational or commercial product inventory and accountability (as applicable)
  • Ensures return of unused study product to designated location or verifies destruction as required.
  • Reviews the quality and integrity of the clinical data through in-house review of electronic CRF data and on-site source verification.
  • Works with sites to resolve data queries.
  • May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.
  • Serves as primary contact between RQM+, sponsor and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
  • Performs study close-out visits per the study specific Clinical Monitoring Plan including final study product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
  • Assists with, and attends, Investigator Meetings for assigned studies.
  • Authorized to request site audits due to data integrity concerns.
  • Attends study-related, company, departmental, and external meetings, as required.
  • Ensures internal and study-related trainings are completed per RQM+ process and/or study timelines, including updating the study level trial management system.
  • Ensures all study deliverables are completed per RQM+ and study timelines.
  • Serves as mentor for junior staff and those new to the company and/or study.
  • Performs other duties, as requested

Requirements

  • Bachelor's Degree in scientific discipline or health care preferred.
  • Requires at least 2 years of year of on-site monitoring experience.
  • 2-3 years in-house or remote monitoring experience
  • Equivalent combination of education, training and experience considered
  • In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. MedTech regulations and active experience preferred.
  • Strong therapeutic and protocol knowledge as provided in company training.
  • Computer skills including proficiency in the use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and mobile technology required.
  • Written and verbal communication skills including command of English language.
  • Organizational and pragmatic problem-solving skills
  • Effective time and financial management skills
  • Ability to establish and maintain effective working relationships with coworkers, managers, sponsor staff and sites.
  • Ability to travel up to 50%
  • Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning

RQM+ Home Page

  • Candidate Eligibility

SOCRA offers one comprehensive clinical research certification so there is no need to obtain multiple certifications when you transition to varying roles in the clinical research arena. Available to all persons working in clinical research: SOCRA members enjoy reduced certification fees, while non-members receive complimentary SOCRA membership upon passing the exam. Whether you are independent or affiliated with a research institution, or you're an investigator, coordinator, monitor, nurse, or any other role – SOCRA's CCRP is your credential of excellence.

Eligibility Criteria

The applicant must meet one of the following Eligibility Criteria noted below.   Please note that most candidates will be eligible under Category 1.

The applicant must be working with Good Clinical Practice (GCP) guidelines under IRB/IEC/REB-approved (or specifically exempted) protocols.

For purposes of eligibility, please view SOCRA's definition of a Clinical Research Professional .

If you have a question about Candidate Eligibility please email SOCRA at  [email protected]

Applicant must have (and be able to document) ALL of the following qualifications:

  • Have two years of experience as a full-time Clinical Research Professional (or have 3,500 hours part-time) during the last five years

Please note:  If you have completed two (2) years of full-time employment as a clinical research professional in the past five years, you will NOT need to provide supporting documentation for your educational experience.

  • Hold a degree in "Clinical Research conducted with humans according to the principles of Good Clinical Practice GCP" from an Associate, Undergraduate, or Graduate Degree Program AND
  • Have completed a minimum of one year of full-time experience (or 1,750 hours part-time) during the past two years as a Clinical Research Professional
  • Hold an Undergraduate or Graduate Certificate in “Clinical Research conducted with humans according to the principles of Good Clinical Practice GCP" with a curriculum of no less than 12 semester (credit) hours or totaling a minimum of 144 credit hours from an academic institution of higher learning (community college, college or university) AND
  • Hold an Associate’s or Bachelor’s Degree in a science, health science, pharmacy or related field AND
  • Have completed a minimum of one year of full-time experience (or 1750 hours part-time) during the past two years as a Clinical Research Professional .

Certification

  • Program Overview
  • CCRP Certification Quick Facts
  • Definition of a Clinical Research Professional
  • Certification Program Policies
  • Removal of CCRP® Credential
  • Verify Certification
  • Exam Overview
  • Application and Fee
  • Computer Based Testing Exams
  • Paper and Pencil Exams
  • Refunds, Rescheduling and Retesting
  • SOCRA Sponsored Exam Schedule
  • Preparing for the Exam
  • Preparation Resources
  • Examination Results
  • Host an Exam at Your Site
  • Apply Online
  • Exam Schedule SOCRA Sponsored Sites
  • Requirements for Maintaining Certification
  • Continuing Education Requirements
  • Descriptions of Acceptable CE
  • CE Recordkeeping Requirements
  • Request for SOCRA CE for Courses / Workshops
  • Installment Plan Payment
  • Renewal of Certification
  • Recertification Audit
  • Recertification Learning Module
  • Accreditation

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ACHIEVING EXCELLENCE IN CLINICAL RESEARCH :

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September 27 to 29

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Join us for expert-led sessions, interactive workshops, a peer-driven poster program, an engaging exhibit program and unparalleled networking opportunities!

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How to get a job in clinical research

Need some guidance on how to get a job in clinical research?

Clinical research is a dynamic and rewarding field that transcends borders, offering professionals worldwide the chance to contribute to medical advancements and improve patient outcomes.

If you're considering a career in clinical research and want to explore global opportunities, follow this comprehensive guide to help you embark on a fulfilling journey focusing on opportunities in Europe and the UK.

Step 1: Lay the educational foundation

Your journey into global clinical research begins with a strong educational background. 

Most positions in the field require at least a bachelor's degree in life sciences or a relevant discipline such as biology, pharmacology, nursing, pharmacy, or a related field. To excel and access advanced roles, consider pursuing a Master's or Ph.D. degree.

clinical research job requirements

Step 2: Gain practical experience

Hands-on experience is invaluable in clinical research. As a global leader in clinical research, IQVIA could be your gateway to exciting international roles in this thriving industry.

If you’re new to the field, start by seeking internships, volunteer roles, or entry-level clinical research assistant positions within clinical settings, pharmaceutical companies, research institutions, or hospitals across Europe and the UK. 

This real-world exposure will equip you with the skills and insights necessary for a successful career.

Step 3: Explore diverse roles

Explore common job titles in the field to understand what’s out there and where your strengths lie.

Global clinical research offers various roles, from clinical research coordinator to data manager, clinical research associate, and principal investigator.

Explore various positions to identify the one that aligns with your interests and career aspirations. Starting as a clinical research coordinator can provide an excellent entry point with opportunities for career progression.

Step 4: Develop essential skills

Success in clinical research demands a diverse skill set, including:

● Attention to detail: Precise data collection and analysis are essential for accurate results.

● Effective communication: Strong interpersonal skills are crucial for collaboration with international teams, patients, and sponsors.

● Ethical conduct: Upholding ethical standards ensures patient safety and data integrity.

● Data management: Proficiency in data collection, analysis, and management tools is essential in trials and research.

● Regulatory knowledge: Familiarise yourself with global and country-specific regulations governing clinical research, such as Good Clinical Practice (GCP) , an internationally recognized set of ethical and scientific quality requirements for conducting clinical trials.

Step 5: Build a global network

Establishing a professional network is key to your global clinical research career. Attend international conferences, seminars, and workshops to meet industry experts, connect with fellow professionals, and stay updated on global developments.

Consider joining organizations like the European Medicines Agency (EMA) or the Institute of Clinical Research (ICR) for access to valuable resources and networking opportunities.

Step 6: Stay informed on global trends

The clinical research landscape is continually evolving worldwide. Stay informed about emerging technologies, innovative methodologies, and global regulatory updates by reading industry publications, participating in international webinars, and engaging in ongoing education programs.

Remaining well-informed positions you as a valuable asset in the global clinical research field.

Step 7: Prepare for international interviews

When applying for clinical research positions globally, prepare for interviews that may include questions about your international experience, ethical considerations, problem-solving abilities, and knowledge of global regulatory requirements.

Showcase your relevant skills and experiences to demonstrate your suitability for the role.

If you’re based in a country different from the role you’re applying for and have been invited to an online interview, prepare just as you would for an in-person interview.

Here are some bitesize tips to help you ace a video interview:

● Tech check: Download needed apps/software for smooth video interviews. To mitigate technology disruptions, provide your recruiter a back-up phone number in advance

● Know-how: Research the organization beforehand and have your resume ready. For example, if you’re interviewing at IQVIA, go beyond the ”about us” page, follow us on social media to get a sense of life at IQVIA, or read our blogs for valuable insights.

● Question ready: Prepare for common questions and have your own ready.

● Distraction-free zone: Find good lighting, silence your phone, declutter your background, and have water handy.

● Dress the part: Dress as you would for an in-person interview.

● Early bird: Log in 5 mins early to ensure everything's set.

● Confidence is key: Smile, stay centered, and maintain focus during the interview.

● Manage interruptions: If disrupted, ask for a moment, put yourself on mute, and resolve.

Step 8: Discover global opportunities with IQVIA

At IQVIA, we offer exciting international opportunities for professionals like you. With a presence in over 100 countries, we provide a platform to work on groundbreaking studies, collaborate with esteemed researchers, and drive innovations in healthcare on a global scale.

Explore the diverse global clinical research jobs available with us today. Whether you are based in Europe, the UK, or anywhere in the world, IQVIA offers a gateway to a fulfilling international career in clinical research.

Join the IQVIA team and be part of a global community dedicated to advancing medical science and improving patient care.

Frequently Asked Questions

What qualifications do you need to be a clinical researcher.

A minimum educational requirement to be a clinical researcher is usually a bachelor's degree in a relevant field such as life sciences, medicine, or nursing. 

Many clinical researchers pursue advanced degrees (master's or PhD) for specialized roles. Additionally, gaining experience through internships or entry-level positions in research is valuable.

How do I move into clinical research?

Transitioning into clinical research involves acquiring relevant qualifications and experience. 

Consider pursuing a degree in a related field, gaining practical experience through internships or entry-level positions, and networking within the clinical research community. Building a strong understanding of research methodologies is key.

Is clinical research in demand?

Yes, clinical research is in demand, particularly as advancements in healthcare and medical treatments continue. 

The pharmaceutical and biotechnology industries and academic and healthcare institutions actively seek skilled clinical researchers. The demand is driven by the need for evidence-based practices and the development of new medical interventions.

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Clinical Research Coordinator Associate (1 Year Fixed Term, Hybrid Opportunity)

🔍 school of medicine, stanford, california, united states.

Dr. Emmanuel Mignot’s laboratory within the Division of Sleep Medicine in the Department of Psychiatry & Behavioral Sciences is seeking a Clinical Research Coordinator Associate to perform duties related to the collection of clinical data and the coordination of clinical studies. The Mignot laboratory in connection with the Center for Narcolepsy combines basic molecular research with translational and clinical research. This position will work under the supervision of the senior clinical research coordinator and will collaborate with a team of clinical research coordinators while taking the lead role and coordinating moderately complex aspects of an ongoing study.

  This position will be located at the Stanford Redwood City campus and has the option of telecommuting/hybrid schedule subject to operational needs. This position is a one-year fixed term for the duration of the study ending in July 2025.

  Duties include:

  • Serve as primary contact with research participants, sponsors, and regulatory agencies.  Coordinate studies from startup through close-out.
  • Determine eligibility of and gather consent from study participants according to protocol.  Assist in developing recruitment strategies.
  • Coordinate collection of study specimens and processing.
  • Collect and manage patient and laboratory data for clinical research projects.  Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
  • Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents.  Prepare regulatory submissions, and ensure institutional Review Board renewals are completed.
  • Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
  • Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
  • Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
  • Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
  • Participate in monitor visits and regulatory audits.
  • - Other duties may also be assigned

DESIRED QUALIFICATIONS:

  • Bachelor’s degree  
  • Valid State of California Certified Phlebotomy Technician I (CPT I) Certificate    
  • 1 year of phlebotomy experience
  • 2 years of related experience in clinical trial coordination.

EDUCATION & EXPERIENCE (REQUIRED):

  •   Two-year college degree and two years related work experience or a Bachelor’s degree in a related field or an equivalent combination of related education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

  • Strong interpersonal skills.
  • Proficiency with Microsoft Office.
  • Knowledge of medical terminology.

CERTIFICATIONS & LICENSES:

  •   Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

PHYSICAL REQUIREMENTS*:

  •   Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. 
  • Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
  • Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
  • - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS:

  • Occasional evening and weekend hours.
  • This position is based in Stanford’s Research Park and Stanford main campus and has the option of telecommuting/hybrid schedule subject to operational needs.

The expected pay range for this position is $31.73 to $36.54 per hour. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

* - Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

  • Schedule: Full-time
  • Job Code: 1013
  • Employee Status: Fixed-Term
  • Requisition ID: 104202
  • Work Arrangement : Hybrid Eligible

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Clinical Research Coordinator II

Apply now Job no: 532754 Work type: Staff Full-Time Location: Main Campus (Gainesville, FL) Categories: Allied Health, Grant or Research Administration, Nursing, Health Care Administration/Support Department: 29170000 - MD-ORTHOPAEDICS / REHAB

Classification Title:

Clinical Research Coordinator II

Job Description:

The Department of Orthopaedics is seeking a Clinical Research Coordinator to join our team. The incumbent of this position will be an integral member of our research team. The incumbent is responsible for collecting clinical data for various studies by screening patients in clinic. This is a "hands on" position with interface with patients and physicians. The coordinator will participate in a wide range of activities, with duties that include: performing data entry; collecting patient data; creating, collecting and processing clinical surveys, assessments and questionnaires; and collecting patient measurements (including range of motion, strength measurements and other outcome data). He/she attends research meetings and communicates study progress to the research team. The coordinator ensures communication among internal and external referring physicians and members of the Health Care Team. He/she communicates and interprets policies and procedures to members of the healthcare team, patients, families and visitors to ensure regulatory compliance and subject safety.

Responsibilities will include:

- Inclusion/exclusion.

- Protocol.

- Documentation.

- Coordination of site visits.

- IRB status.

- Contracts and budget.

- Investigator meetings.

- CFR’s.

- Supplies and equipment.

Correspond with referring physicians regarding Inclusion/Exclusion criteria of research candidates.  Correspond with patients on our studies regarding any questions they have.  Develop educational material for patients and referring physicians to promote patient accrual on clinical trials.  Communicate with nursing staff and physician assistants regarding patient care per protocol.  Communicate with primary investigators.   Consents patients or meets with patients to explain the purpose of studies. Conducts telephone interviews with patients for research purposes. Train physician assistants (PAs) on how to implement the Own the Bone program in their respective clinics. Educate patients on how to prevent secondary fragility fractures utilizing ten standard of care measures.

Expected Salary: $58,000 - $62,000, commensurate with qualifications
Minimum Requirements:

Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.

Preferred Qualifications:

Preferred Qualifications include:

Special Instructions to Applicants:

In order to be considered, you must upload your cover letter and resume.

The University of Florida is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.

This is a time limited position.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Health Assessment Required: Yes

Advertised: 14 Aug 2024 Eastern Daylight Time Applications close: 28 Aug 2024 Eastern Daylight Time

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Position Department Location Closes
29170000 - MD-ORTHOPAEDICS / REHAB Main Campus (Gainesville, FL)
The Department of Orthopaedics is seeking a Clinical Research Coordinator to join our team. The incumbent of this position will be an integral member of our research team. The incumbent is responsible for will participate in a wide range of activities, with duties that include: performing data entry; collecting patient data; creating, collecting and processing clinical surveys, assessments and questionnaires; and collecting patient measurements (including range of motion, strength measurements and other outcome data). He/she attends research meetings and communicates study progress to the research team. The coordinator ensures communication among internal and external referring physicians and members of the Health Care Team. He/she communicates and interprets policies and procedures to members of the healthcare team, patients, families and visitors to ensure regulatory compliance and subject safety.

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Fractyl Health, Inc Logo

Senior Clinical Research Associate

Reports to: clinical trial manager, position summary  .

The Sr   Clinical Research Associate provides trial support for the initiation, execution, and compliance of clinical studies to support both product approvals and market adoption of company products. Working closely with clinical operations and other cross-functional team members, the Sr CRA liaises with vendor teams to ensure successful clinical trial execution, ensuring accuracy and quality results in a cost-effective and  timely manner. S/he assists the Clinical Operations team with establishing key practices, procedures, and processes in preparation for future expansion and growth.  

Primary Responsibilities  

Investigator Relations  

  • Develop and maintain individual investigator relationships, guiding them on protocol data requirements and reviewing their progress on a regular basis  
  • Ensure adherence to ICH-GCP and Regulations  
  • Facilitate scientific discussion on product and protocol requirements  

  Vendor Contracts/Management  

  • Monitor, evaluate and resolve all vendor issues  
  • Drive timelines and provide guidance on all protocol, technology, and data questions  
  • Train and assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets the protocol requirements and timelines/milestones  
  • Liaise with study site staff to ensure timely and accurate CRF data  

  Site Support and Quality Assurance  

  • Conduct Site Evaluation, Site Initiation, Interim Monitoring and Close Out visits  
  • Serve as first point of contact for site staf f  
  • Administer protocol a nd study related training to sites  
  • Monitor clinical sites, assessing any potential discrepancies and working with internal management and clinical site teams to identify and implement resolutions  
  • Manage device/medication accountability and inventory throughout clinical study  
  • Monitor study to ensure sites are in compliance with protocol, SOPs and regulations  
  • Complete accurate monitoring reports and follow up letters in a timely manner  
  • Review clinical study reports for regulatory submissions and follow up on assigned action items and queries  
  • Ensure rights, safety and well-being of trial subjects are protected and the data is accurate and verifiable  
  • Perform source data verification and ensure accuracy and completeness  
  • Ensure quality of the data by performing regular reviews of data according to data review/monitoring guidelines. 
  • The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s). 
  • Provide regular (weekly/biweekly) project communications with Clin Ops regarding key clinically meaningful data
  • Perform all activities in compliance with applicable regulations, Fractyl’s policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training  
  • Bring a “can do” spirit to work and deliver on other responsibilities as assigned  

Education or Certification Requirements  

  • Bachelor’s degree in a science-based discipline  
  • Degree in Nursing preferred  

Professional Work Experience  

  • 5+ years of monitoring experience on clinical trials
  • Applicable experience in biotech, pharmaceutical and/or medical device industries preferred.
  • Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).  

Qualifications and Skills  

  • In depth k nowledge and skill in applying applicable clinical research regulatory requirements (i.e. Good Clinical Practice (GCP) and In ternational Conference on Harmonization (ICH) guidelines  
  • Must have knowledge of and direct experience with Microsoft Office: Word, Excel, PowerPoint, OneNote, Outlook, and Adobe Acrobat.
  • Experience with controlled clinical terminology and clinical trial systems such as TMF/eTMF, CTMS, EDC, IVRS/IWRS, ePRO is highly preferred
  • Excellent organizational and problem-solving skills  
  • Effective time management skills

Other Essentials and Key Success Factors   

  • Successful track record of working in high-growth and dynamic organizations  
  • Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit  
  • Ability to lead fast-paced projects with a keen sense of urgency to get the job done well  
  • Evidence of "hands-on" experience and expertise  
  • Proven and successful track record as a team-player and collaborator in small working environments  
  • Highly organized and detail oriented with a passion to deliver quality results  
  • Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation  
  • Highest levels of professionalism, confidence, personal values and ethical standards  

Travel  

This position requires up to 50-75% travel.  

The description and requirements outlined above are general; additional requirements may apply.  

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Johns Hopkins strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The seasonal flu vaccine requirement remains unchanged. Exceptions may be provided under certain circumstances.  Click here for more information. .

Clinical research site manager.

The Department of Neurology is seeking a Clinical Research Site Manager who will deliver to, and organize work plans with, 20+ collaborating clinical sites across the country in support of clinical trial research goals of the BIOS Clinical Trials Coordinating Center’s (CTCC). Activities include training and managing clinical and data entry personnel at numerous centers regarding specified trial cycle metrics, protocol fidelity, and oversee local, institutional and federally required regulatory compliance across the network of collaborators. The Site Manger will oversee and coordinate the work of teams in other institutions. This position reports to the BIOS faculty and leadership.

Specific Duties & Responsibilities

  • Establish early lines of communication with the clinical teams as they are identified, selected and prepared for activation.
  • Propel accelerated timelines during the trial start-up cycle and during subject accrual, assuring that monthly enrollment goals are met across all clinical sites.
  • Assist with site feasibility evaluations, detailing the availability of critical local resources necessary to be successful at activating trials and enrollment and protocol performance once a trial begins.
  • Assist sites in central IRB on-boarding, ensure timely and accurate submission to IRBs, sponsors and master agreements, local IRB/ethics committee review/approvals, and assist with the collection of all necessary regulatory documents needed before site activation for study subject enrollment.
  • Oversee site compliance with investigational products, reporting or safety events and contracting.
  • During trial implementation oversee site performance, assist with subject eligibility and randomization, identify local recruitment problems, personalize remediation programs with site teams, and help to assure that site investigators quickly implement local solutions to keep the recruitment goal on track for trial completion.
  • Conduct weekly (or more frequent) teleconferences and manage monthly training broadcasts with the clinical teams and individually mentor new coordinators and investigators.
  • Keep enrollments on track and clinical teams on schedule with established performance expectations.
  • Provide support to quality assurance monitors in all facets of work related to communications with and management of the enrolling center clinical teams.
  • Responsible for managing site investigator relationships and executing site start up and performance plans, assigning tasks and deadlines to site clinical teams, directing and monitoring clinical site work efforts on a daily basis, identifying resource needs, performing quality reviews, and escalate functional, quality and timeline issues appropriately.
  • Execute lean management processes and methodologies to ensure sites deliver on-time and within the budget, adhere to high quality standards, and benefit the investigative effort by ensuring smooth implementation of trial policies and goals from site launch through study activation and completion of the trial at the local levels.
  • Perform self-audits and audit performance of clinical sites; recommend changes to protocol operations based on audit results and revised goals.
  • Responsible for tracking proposals and other documentation through signature/approval processes then through collaboration with contracts personnel and IRB Navigators.
  • Use professional judgment in handling information and be sensitive to project team, individual and all levels of organizational concerns; make use of data, statistical and quantitative analysis, explanatory and predictive modeling and fact-based management to drive decision making; and help investigators develop new insights and understanding of performance-based data.
  • Liaison and facilitate meetings between project stakeholders and leadership and complete and maintain professional documentation for projects and deliverables, develop SOPs as needed, and assist in the auditing and monitoring of study sites.
  • Build and maintain strong, trusting relationships
  • Stay current with a constantly changing clinical research technology and embrace the adoption of innovations to modernize, disseminate, renovate and remodel.
  • Serve as a knowledgeable liaison between the BIOS leadership and the research communities.

Additional Knowledge, Skills & Abilities

  • Understands and can apply knowledge of clinical trial designs to trial execution.
  • Excellent negotiation, facilitation, consensus-building, and diplomacy skills, and a strong helpline orientation.
  • Exhibit a high degree of independent action and adherence to strict timelines.
  • Ability to operate independently, with guidance provided by BIOS leadership.
  • Ability to make independent judgments and act on decisions on a daily basis
  • Ability to work for long periods of time without direction
  • Ability to prioritize one’s own work and the work of others.
  • Ability to work with flexibility on several tasks simultaneously and to meet various concurrent deadlines.
  • Strong organizational skills, analytical and problem-solving abilities, and attention to detail
  • Ability to coordinate multiple sites independently and work constructively as part of a leadership team.
  • Excellent leadership skills with ability to negotiate and work collaboratively.
  • Service-oriented with excellent verbal and written communication and organization skills.
  • Ability to prioritize own work and work of others daily and weekly.
  • Strong organizational skills, analytical and problem-solving abilities, and attention to detail.
  • Ability to work with flexibility on several trials simultaneously and to meet various concurrent deadlines.
  • Proficient in Microsoft Office Suite: Outlook, Word, Excel, PowerPoint, and Teams.
  • Proficient with SharePoint, collaborating and co-authoring of documents.
  • Ability to learn new software programs such as electronic data capture software, eIRB, and project management software, which will be taught on the job.
  • Bachelor's Degree required in related field.
  • Five (5) years’ experience in delivering effective clinical research management solutions.
  • Additional education may substitute for required experience and additional experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
  • Project/system process lifecycle experience, including 2+ years of direct project management.
  • Knowledge of formal project management methodologies.
  • Experience representing trial policies and communicating scientific concepts to investigative teams, end-users (faculty and staff), and subject-matter experts
  • Experience in research protection, federal and regulatory issues, research ethics, pharma law, pharmacovigilance, regulatory compliance, use of centralized IRBs and master agreements, and project management at the task level.
  • Experience in a higher education environment.
  • Experience with REDCap preferred.
  • Advanced knowledge and experience with GCP/ICH and local regulations.
  • Experience in web-based data collection applications.

Classified Title: Clinical Research Site Manager  Role/Level/Range: ACRP/04/MD   Starting Salary Range: $55,800 - $97,600 Annually (Commensurate with experience)  Employee group: Full Time  Schedule: M-F 8:30 am - 5:00 pm  Exempt Status: Exempt  Location: Remote  Department name: SOM Neuro BIOS   Personnel area: School of Medicine 

Total Rewards The referenced base salary range represents the low and high end of Johns Hopkins University’s salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education/training and other qualifications. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/ .

Education and Experience Equivalency Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.

Applicants Completing Studies Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.

Background Checks The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

Diversity and Inclusion The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion .

Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

EEO is the Law https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

Accommodation Information If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the Talent Acquisition Office at [email protected] . For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit https://accessibility.jhu.edu/ .

Vaccine Requirements Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine . Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry.  This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/  and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/ .

The following additional provisions may apply, depending upon campus. Your recruiter will advise accordingly. The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.

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Clinical Research Coordinator - Pediatrics

  • Madison, Wisconsin
  • SCHOOL OF MEDICINE AND PUBLIC HEALTH/PEDIATRICS-GEN
  • Partially Remote
  • Staff-Full Time
  • Staff-Part Time
  • Opening at: Aug 16 2024 at 13:45 CDT
  • Closing at: Aug 30 2024 at 23:55 CDT

Job Summary:

Want to join a fun, hard-working, collaborative team? Come join the Pediatric Clinical Research Coordination team! The UW Pediatric Clinical Research Coordination team supports clinical research across multiple divisions in the Department of Pediatrics. This is a unique opportunity to contribute to research aimed at prevention, detection, and treatment of disease in children. This position will assist with coordinating a variety of clinical research studies by performing various tasks and activities. These tasks include but are not limited to recruitment, screening, and enrolling study participants and families as well as ensuring study participants and families follow the research study protocol. Our team of clinical research coordinators and research nurses apply expertise, knowledge, and skills to a broad range of clinical studies, navigate resources, identify issues requiring escalation, and contribute to the development of new team and unit processes, procedures, and tools. The Clinical Research Coordinator will work in collaboration with pediatric faculty, nurses and staff to coordinate clinical research studies for the Department of Pediatrics ranging from industry partnered to PI initiated clinical trials.

Responsibilities:

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Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals. The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world. For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion

Preferred Bachelor's Degree

Qualifications:

Required: 1. Experience in a clinical research or healthcare setting Strongly preferred qualifications include: 1. Minimum of one year working in a clinical research role 2. Experience working with the pediatric population 3. Experience working with research data collection and/or sample processing 4. Experience utilizing a variety of platforms including Health Link or other electronic medical record, Microsoft Office Suite, REDCap, OnCore, and Google Drive 5. Clinical Research Certification Additional Knowledge, Skills, & Abilities: 1. Effective oral and written communication skills 2. Ability to manage multiple projects at the same time 3. Excellent attention to detail and organization skills 4. Excellent time management and prioritization 5. Ability to independently and creatively problem solve

Full or Part Time: 90% - 100% This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location.

Appointment Type, Duration:

Ongoing/Renewable

Minimum $47,000 ANNUAL (12 months) Depending on Qualifications Actual pay will depend on experience and qualifications. Employees in this position can expect to receive benefits such as generous vacation, holidays, and paid time off; competitive insurances and savings accounts; retirement benefits. Benefits information can be found at https://hr.wisc.edu/benefits/ .

Additional Information:

This position will generally be based in a general pediatric clinic at Union Corners to recruit for clinic based research studies. There is still the opportunity to work remotely at least 1 day per week. This position is required to travel to multiple sites around Madison to facilitate recruitment and enrollment so the candidate should have access to reliable transportation or a willingness to use public transportation. University sponsorship is not available for this position, including transfers of sponsorship. The selected applicant will be responsible for ensuring their continuous eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without the need of an employer sponsorship) on or before the effective date of appointment. This position is an ongoing position that will require continuous work eligibility. UW-Madison is not an E-Verify employer, and therefore, is not eligible to employ F1-OPT STEM Extension participants. If you are selected for this position you must provide proof of work authorization and eligibility to work. This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years. This position vacancy listing is announced simultaneously with a Research Nurse posting, PVL 303690. Please note that only one vacancy exists. One person will be hired to fill the position under either Clinical Research Coordinator or Research Nurse.

How to Apply:

To apply for this position, please click on the "Apply Now" button. You will be asked to upload a current resume/CV and a cover letter briefly describing your qualifications and experience.

Kelsey Scholtens [email protected] 608-262-0006 Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Official Title:

Clin Res Coord I(RE015) or Clin Res Coord II(RE016)

Department(s):

A53-MEDICAL SCHOOL/PEDIATRICS/PICU

Employment Class:

Academic Staff-Renewable

Job Number:

The university of wisconsin-madison is an equal opportunity and affirmative action employer..

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