Clinical Research Associate (CRA) – A Growing Career Path in Biotechnology

A clinical research associate (CRA) is a professional who oversees all aspects of clinical trial conduct. They oversee clinical trials to test drugs/medical devices/biologics/or in vitro diagnostics for their effectiveness, risks and benefits to ensure they are safe to allow on to the market. CRAs are also known as clinical trial monitor or clinical monitor. A CRA may be involved in some or all stages of the clinical trial depending on the type of position and the employer a CRA work for.

Different pathways toward a CRA role

Similar to my career path, those without experience can get into clinical research at a lower level. These starting positions may be directly or indirectly applicable to clinical research industry. Once experience has been gained, a clinical research associate (CRA) position can be pursued using the applicable skills and knowledge acquired.

Directly applicable starting positions may include:

· Clinical research coordinator (CRC) role at a clinical site

· Clinical trials associate (CTA) role at a sponsor company

· Nursing role with patient care experience.

Indirectly applicable starting positions may include:

· Pharmacy or medical sales

· Clinical laboratory work

· Clinical data work

· Academic or pharmaceutical research

Clinical Research Training

Although experience is the key toward a CRA position, there are training programs that are offered through colleges and universities as well as online training courses that can help increase the chance for a candidate who looks to get into clinical research. These may include postgraduate degree and certificates in clinical research. The cost and time investment for these training programs should be considered carefully and compared to the pathways listed above for pros and cons. Training may also be done part-time while one work full time in one of the starting positions in clinical research. Specific curriculum will vary from institution to institution. Below are some general areas that a clinical research training program should cover:

· clinical research ethic

· clinical research practice

· clinical trial design

· clinical document writing (study design, protocol, informed consent, case report forms, etc.)

· clinical trial monitoring and management

· risk management

· regulatory requirements

Career Development

Career progression can be different depending on company and business environment. However, with motivation and previous experience showing success in clinical research, one should be able to progress either within the same company or at another company. Below are different levels of CRA title that we can use as a rough guide in gauging CRA career progression:

CRA Title

· CRA I – starting level with 1-2 years of experience. CRA I may be working on different parts of clinical trial, such as setting up trial master files, document preparation, and site correspondence. Some supervision from more senior CRA may be needed to help guide CRA I on different clinical trial related functions.

· CRA II – mid level with 3-5 years of experience. CRA II should be working on all stages of clinical trial. Job function can range from clinical trial design and planning, protocol and form generation, site selection, monitoring, to clinical report generation. CRA II should be working independently with little or some supervision from more senior CRA.

· CRA III / Senior CRA / Lead CRA – senior level with 5 or more years of experience. CRA III, Sr. CRA, or Lead CRA should be able to perform any of the clinical trial tasks proficiently. They are also expected to supervise, train, and mentor more junior CRA.

Beyond A CRA Role

Many CRAs may choose to remain in CRA role as a career. Some CRAs may become consultants after gaining years of experience. Beyond a CRA role, career progression may include management role such as:

· Clinical trial or clinical affairs manager

· Senior clinical trial or clinical affairs manager

· Associate director of clinical research

· Director / vice president of clinical research

The sky is the limit for opportunities and career progression beyond a CRA role. One note is that advance degree (M.D., Ph.D., MBA, etc.) may be advantage as one progress higher in clinical research career.