Clinical Research Associate Certification and Certificate Programs
A clinical research associate (CRA) monitors clinical trials and studies as an independent freelancer or for a research organization. Those aspiring to become a clinical research associate must first finish either an undergraduate or graduate certificate program.
CRAs meet with patients, practice FDA-approved methodology, conduct research and ensure that clinical trials adhere to established state and national regulations. Undergraduate and graduate certificate programs are available in this field, and these typically require a commitment of one academic year. Voluntary certification is available through the Association of Clinical Research Professionals or the Society of Clinical Research Associates.
- Program Levels in Clinical Research: Undergraduate certificates, graduate certificates
- Prerequisites: Bachelor's degree, some programs may require prerequisite courses
- Program Length: One year
Certificate in Clinical Research Associate
A certificate program in clinical research associate (CRA) is aimed towards clinical research coordinators (CRC) and other professionals working in clinical research. Graduates who are clinical research associates (CRAs) may work in the medical device, biotechnology or pharmaceutical industries as opposed to hospitals or research institutions.
Admission to the certificate program in clinical research associate requires a bachelor's degree or higher. Clinical research experience is an asset. A background in the life sciences, nursing, pharmacy or medicine is preferred. Applicants who are CRCs may enroll in the program with no additional requirements.
CRAs must possess strong writing and speaking skills to communicate effectively with doctors, program participants and the other researchers. In addition to completing the program's curriculum, students need proficient computer skills, as well as being well versed in a spreadsheet application. Typical coursework includes:
- Clinical trial ethical issues
- Process of discovery and approval of drugs
- Medical terminology
- Clinical trials data management
- Monitoring plan
Certificate of Completion in Clinical Trials Management
This certificate program is generally offered through a university's extension department for CRAs, CRCs, physicians, nurses, pharmacists or other professionals interested in the field of clinical trials. Students learn about the entire process of approving new medical devices and drugs.
CRAs may enroll in this program without further requirements. Courses in this certificate program may be acceptable as continuing education credits for CRAs wishing to recertify.
A clinical trials management graduate certificate program introduces students to implementing and managing clinical trials. Typical curriculum coursework includes:
- Clinical practices and clinical trial design
- Drug development process
- Fundamentals of clinical monitoring
- Clinical research statistics
- Reporting adverse events
- Development and design of medical devices
Popular Career Options
Graduates of a certificate program are equipped with the knowledge and skills to become general practitioners in numerous clinical research-type jobs. Examples of careers include:
- Regulatory administrator
- Clinical research coordinator
- Project manager
Salary Information and Employment Outlook
The U.S. Bureau of Labor Statistics (BLS) does not keep separate statistics on clinical research associates, but their duties can be considered similar to medical scientists (www.bls.gov). Growth in employment for medical scientists or individuals working in the biotechnology industry is anticipated to be 13% from 2012-2022. According to the BLS the median salary for clinical research associates was $79,930 as of May 2014.
Professional Certification and Continuing Education
Certification for clinical research associates is offered by the Association of Clinical Research Professionals or Society of Clinical Research Associates. Once candidates meet requirements and pass a written exam, applicants will be certified as CCRAs (certified clinical research associates) or CCRPs (certified clinical research professionals for SoCRA certification). Both certifications are voluntary.
ACRP's certification requirements include a combination of a degree, completion of a clinical research program and work experience calculated in hours. For example, applicants with just an associate degree would need 4,500 hours of work experience to qualify. An applicant with an associate degree and clinical research education would only need 3,000 hours of work experience.
Similarly, applicants must also meet SoCRA's educational and work experience requirements prior to taking its examination. Applicants who do not have formal training in clinical research would need two years of experience in the last five years to qualify. Applicants with formal education need less work experience.