How Do You Become a Clinical Research Coordinator (CRC)?

A clinical research coordinator (CRC), sometimes called a clinical trial manager, plays an integral role in medical studies. They typically work under the direction of the principal investigator (PI), who is in charge of designing, conducting, and managing the clinical trial from a high level. The CRC’s job is to support, facilitate, and organize daily clinical trial activities.

Clinical research coordinators also work with the department, sponsor, and institution to guide them through compliance, finances, and personnel issues. In short, the CRC manages the day-to-day clinical operations activities, overseeing and executing delegated tasks to appropriate parties.

Key responsibilities of the CRC include planning and managing the study, enrollment, maintenance, training initiatives, and maintaining compliance with federal, state, and institutional regulations. In addition, they carry out experiments, clinical research, and medical studies. They also engage directly with the trial participants as they screen them for eligibility, develop and implement recruitment strategies, and liaise with all teams throughout the trial. From evaluating research protocols to seeking approval from regulatory committees, CRCs have a broad reach within laboratories, medical centers, and research hospitals.

To secure a job as a CRC, professionals must have at least a four-year bachelor’s degree in a field such as medical technology, microbiology, or public health administration. However, some employers require an additional two-year master’s degree, particularly for management positions.

Typical courses to prepare for this career include biochemistry, biostatistics, healthcare management, mathematics, epidemiology, and human anatomy. Essential job skills include management and communications experience, multi-tasking, and interpersonal skills. In addition, students may have to take and pass a licensing exam to become clinical research coordinators. (See more on certification below).

Additionally, students may consider internships or entry-level jobs working as lab technicians or healthcare workers to get familiar with the typical working environment.

As the medical industry grows, college graduates, especially those with a master’s in clinical research, will be on the front lines of research and development. As a result, students have various career prospects in front of them with an education in clinical research, from medical scientists to natural sciences managers.

Continue reading for a comprehensive guide on achieving the various levels of a clinical research career, followed by helpful resources that can guide students and professionals as they navigate the process.

Becoming a clinical research coordinator involves many steps, and varied career pathways are available. Below are some of the primary steps to becoming a CRC at different educational stages.

Step 1: Graduate from high school (four years).

Preparation for a career in clinical research coordination should begin with high school chemistry, biology, physics, math, and communications courses that develop foundational knowledge for college-level coursework.

Step 2: Obtain a bachelor’s degree (four years).

When pursuing colleges and universities, students should focus on those offering bachelor of science degrees in health sciences in clinical research administration. Students should dedicate at least four years of full-time work to this degree. These programs generally provide clinical research professionals with the tools to develop medicines and conduct trials and studies. In addition, on-campus and online programs focus on critical administrative and scientific methods regarding clinical research and guidelines to protect human subjects.

George Washington University

For example, George Washington University in Washington, DC, offers a robust online program geared toward working health sciences and clinical research professionals looking to advance in their careers. With an online BSHS (bachelor of science in health sciences) in clinical research administration from George Washington University (GW), students will develop the expertise and skills needed to contribute to the rapidly growing field of clinical research.

The program comprises 120 credits. In addition to the 51 credits, students will need to take nine to 24 credits depending on how many hours they transferred in. Students may transfer 45 to 60 college credits from another institution which are applied toward the general education and advanced standing requirements. Students must earn at least 60 credits at GW to meet the academic residency requirement and fulfill the required courses for the major.

The curriculum includes courses such as basics of clinical research; processes of clinical research; good clinical practices; introduction to monitoring clinical trials; strategic communication for health professionals; pathophysiology; introduction to statistics for health science; introduction to medical informatics; and introduction to regulatory affairs.

• Location: Washington, DC
• Accreditation: Middle States Commission on Higher Education (MSCHE)
• Expected Time to Completion: 24 months

Kent State University

The College of Public Health at Kent State University in Kent, Ohio, offers a bachelor of science in public health (BSPH) program with a concentration in clinical trials research. Offered on-campus and online, this program prepares students for work as clinical trial researchers and managers.

The program emphasizes epidemiology and health research. Required classes in this 120-credit program include clinical epidemiology basics; clinical trial management; scientific writing for clinical research; and an internship in clinical research. Graduates from this program work for contract research organizations, pharmaceutical companies, hospitals, medical schools, universities, and insurance companies.

• Location: Kent, OH
• Accreditation: Council on Education for Public Health (CEPH); Higher Learning Commission (HLC)
• Expected Time to Completion: Eight semesters

A bachelor’s degree can lead to an entry-level position in a clinical organization or institution. It can also help existing clinicians advance within their current jobs. Students wishing to open up even more opportunities for responsibility and salary are encouraged to pursue professional experience and additional education.

Step 3: Gain work experience as a clinical research professional (at least one year).

At this stage, earning at least one year of full-time experience working in a clinical research capacity is advisable. This is a typical requirement to qualify for national certification.

Step 4a: Obtain a graduate certificate (optional, one year).

Students can earn an online graduate certificate in clinical research administration.

George Washington University

George Washington University offers three online graduate certificates in clinical and translational research, clinical research administration, and clinical research practice.

The 21-credit graduate certificate in clinical and translational research quickly prepares graduates for roles such as clinical trial investigators on multi-site projects. Courses include critical analysis of clinical research; clinical investigation; foundations in clinical and translational research; grantsmanship in translational health science; and leadership, professionalism, and team science in clinical and translational research.

The 12-credit graduate certificate in clinical research administration prepares graduates to become strategic leaders who drive success for organizations in the clinical research industry. Courses include Introduction to global regulatory affairs and clinical research; regulatory strategy in the development of therapeutics; the clinical research industry; and quality and risk management.

The 15-credit graduate certificate in clinical research practice prepares graduates for evidence-based practice as principals or co-investigators in clinical research. Courses include research methods for clinical and translational research, clinical investigation, biostatistics for clinical and translational research, and epidemiology translational research.

Students can typically transfer credits earned in certificate programs into a master’s program within the same institution.

• Location: Washington, DC
• Accreditation: Middle States Commission on Higher Education (MSCHE)
• Expected Time to Completion: Clinical and translational research (20 months); clinical research administration (14 months); and clinical research practice (12 months)

Arizona State University

Arizona State University’s Edson College of Nursing and Health Innovation also offers a 15-credit online graduate certificate in clinical research management for those who are looking to increase their knowledge of clinical research and gain a strong foundation as they advance their careers. Students in this program will learn about clinical research regulations, ethics, operations, and data management.

To be eligible, applicants must have completed six months of clinical research experience.

The curriculum includes courses such as responsible conduct of clinical research; clinical research data management and technology implementation; fundamentals of regulatory affairs; and clinical research operations.

• Location: Phoenix, AZ
• Accreditation: Higher Learning Commission (HLC)
• Expected Time to Completion: Less than a year

Step 4b: Get a master of science in clinical research management (optional, two years).

Obtaining a master’s degree can increase one’s salary prospects and responsibilities within the field.

Arizona State University

For example, ASU’s master’s in clinical research management is an online 33-semester program. A six-semester-hour clinical research project is also required.

Typical courses include clinical research monitoring; fundamentals of regulatory affairs; clinical research operations; clinical research data management and technology implementation; responsible conduct of clinical research; scientific and research review boards; clinical research design and methods; quality assurance and clinical research; and medical device development and regulation.

By the program’s conclusion, students are prepared to seek careers as clinical research coordinators, data managers, social science research assistants, and clinical lab techs.

• Location: Phoenix, AZ
• Accreditation: Higher Learning Commission (HLC)
• Expected Time to Completion: Two years

Step 5: Get certified (timeline varies).

Professionals in this field are strongly recommended to be certified in clinical research. For example, the Society of Clinical Research Associates (SOCRA) offers an internationally accepted certification for professionals to be recognized as Certified Clinical Research Professionals (CCRP®s).

Students must pass an exam to get their certification. The exam schedule is varied and offers time slots at locations all over the United States. There are three distinct pathways to be eligible for this exam. First, applicants must fall into one of the following categories:

• Category 1– Has two years of full-time experience as a clinical research professional (or 3,500 hours part-time during the previous five years)
• Category 2 – Holds a degree in clinical research (associate, bachelor’s, or master’s) and at least one year of full-time experience as a clinical research professional (or 1,750 hours part-time during the previous two years)
• Category 3 – Holds an undergraduate or graduate certificate in clinical research (at least 12 semester hours or 144 credits); an associate or bachelor’s degree in a scientific (or related) field; and at least one year of full-time experience as a clinical research professional (or 1,750 hours part-time during the previous two years)

Alternatively, students can seek certification from the Association of Clinical Research Professionals, called the ACRP-CP®. There are three levels of certification: clinical research associate (CCRA), clinical research coordinator (CCRC), and principal investigator (CPI). In addition, ACRP offers prep courses to help students prepare for each test.

To be eligible for the CCRA or CCRC certification exam, candidates have two available pathways:

• Pathway 1 – Clinical research professionals with 3,000 hours of verifiable work experience can sit for the CCRC or the CCRA Exam.
• Pathway 2 – Clinical research professionals with 1,500 hours of verifiable work experience and a clinical research degree can sit for the CCRC or the CCRA Exam.

Please note that there may be substitutions for hours of qualifying work experience and that “designated duties” may differ by the desired certification. Students can learn more about the ACRP’s exam, schedule, application, and eligibility requirements on the organization’s website.

Additionally, the Certified Clinical Research Professionals Society offers several clinical research certification training courses. The content is delivered on-demand to accommodate people’s busy schedules without compromising the highest-quality professional standards.

Here are the several levels of certification and their eligibility requirements:

• Advanced ICH-GCP Certification (AGCPC): The only diplomas needed to enroll in this program are high school or equivalent level education (such as GED).
• Advanced Clinical Trial Assistant Certification (ACTAC): This certification is open to everyone, even to those without a high school diploma or equivalent. High school students intending to work after graduation or interested in healthcare research may benefit from completing this clinical research assistant certification.
• Advanced Clinical Research Coordinator Certification (ACRCC): Candidates must possess a minimum of an associate’s degree.
• Advanced Clinical Research Associate Certification (ACRAC): In order to enroll for this certification, candidates must have a bachelor’s degree in life science or a health-care science, or a graduate degree in medicine.
• Advanced Pharmacovigilance and Argus Safety Certification (APVASC): Candidates for this possess a minimum of bachelor’s degree in life science OR a health-care science
• Advanced Physician Medical Monitor Certification (APMMC): To qualify, trainees must have a degree in medicine, a non-US degree in medicine, or a master’s degree in pharmacy. Physicians with one or more years of exposure to medical research may also qualify.
• Advanced Principal Investigator Physician Certification (APIPC): To be a certified PI, candidates must be practicing physicians. They may also either be the PI or Co-PI of an ongoing clinical research study or have been the ex-PI or former Co-PI of a completed study.

The following list of professional organizations can assist students and professionals in seeking a career in clinical research.

• National Institutes of Health – The National Institutes of Health offers a free course, “Introductions and Principles and Practice of Clinical Research (IPPCR).” This clinical research coordinator training course focuses on the ethical issues involved in human subject research. It provides an overview of scientific methodologies, principles, and practices required for patient-oriented research. The course is designed for medical and public health professionals or anyone aspiring to join a clinical research career. Topics include ethical issues, biostatistical methods, study design, protocol preparation, patient monitoring, and quality assurance.
• Harvard University’s Clinical and Translational Science Center – The HCCRC offers information for research coordinators. These resources address professional development, training and certifications, helpful tools, and core competencies for the clinical research professional.
• International Association of Clinical Research Nurses – The IACRN is a professional nursing organization that defines, validates, and advances clinical research nursing while supporting the professional development of registered nurses who work with clinical research participants.
• Association of Clinical Research Professionals—The ACRP sets the standards for competence in clinical research. Based in Washington, DC, it boasts over 16,500 members and supports professionals with the membership, training, and certification programs they need to maintain career excellence.
• Oregon Health & Science University – OHSU’s Oregon Clinical and Translational Research Institute’s mission is “To enhance the efficiency and quality of rigorously translating research ideas into impact.” This organization provides various helpful resources and webinars to guide students as they gather the information necessary to pursue a career in clinical research coordination.

Matt Zbrog

Writer

Matt Zbrog is a writer and researcher from Southern California. Since 2018, he’s written extensively about emerging issues in healthcare administration and public health, with a particular focus on progressive policies that empower communities and reduce health disparities. His work centers around detailed interviews with researchers, professors, and practitioners, as well as with subject matter experts from professional associations such as the American Health Care Association / National Center for Assisted Living (AHCA/NCAL) and the American College of Health Care Executives (ACHCA).