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

Clinical research associate (CRA) is a professional who oversees all aspects of clinical trial conduct. 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.

Type of CRA

In-House CRAs

CRAs who work for a sponsor company are called in-house CRAs. An in-house CRA may be overseeing all aspect of clinical trial conduct, from planning to clinical study report (CSR) generation for submission to regulatory bodies. Below are some job functions of an in-house CRA.

•Designs study documents such as, study designs, synopsis, site specific protocols, informed consent forms, case report forms, site study procedure manuals and project tools, monitoring plans, and tracking tools, clinical study reports, budget, and contract negotiation.

•Performs independent monitoring of sites including: conducting site pre-qualification, initiation, monitoring visits, and close-out visits.

•Maintain frequent contact with and work effectively with investigators and coordinators.

•Coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects.

•Review and resolve discrepancies in clinical data with clinical sites or through a contract research organization (CRO).

•Low amount of travel may be required (e.g. up to 25-30%).

Regional CRAs / Home-Based CRAs

CRAs who work independently from home are called regional CRAs or home-based CRAs. Regional or home-based usually don’t handle planning and preparation of clinical trials. They generally handle the monitoring function and oversee trial conduct. Thus, they can work from home and they usually travel quite a bit more than their in-house CRA colleagues.

•Performs independent monitoring of sites including: conducting site pre-qualification, initiation, monitoring visits, and close-out visits.

•Maintain frequent contact with and work effectively with investigators and coordinators.

•Coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects.

•Review and resolve discrepancies in clinical data with clinical sites.

•High amount of travel may be required (e.g. up to 75-80%).

CRAs Who Work For a CRO

CRAs who work for a contract research organization (CRO) can be either in-house CRA or monitoring CRA. They usually work out of a CRO’s office. As the goal of the CRO is to provide full range clinical trial services to sponsor companies, CRAs who work for a CRO may be called upon to perform in-house or monitoring functions depending on the project and client’s needs. A CRA position at a CRO is usually a good way for a new CRA to gain experience. Another benefit in working at a CRO is getting exposure to a variety of therapeutic areas that may enhance a CRA’s credential and career progression.

Education and Skills Needed

Education

Although there are no exact rules, general educational requirements for a CRA role is typically a bachelor of science (BS) or a bachelor of art (BA) degree in life sciences, medical sciences, or healthcare related field such as nursing. Advanced degree is not required, but can be helpful for career progression.

Skills

CRAs perform variety of functions relating to clinical trial. As different functions require different skill sets, below are some skills that can be helpful in a CRA’s job performance:

•Excellent communication skills (both written and oral).

•Ability to motivate and train others. This goes along with the communication skills.

•Attention to details.

•Problem solving skills.

•Multi-tasking, time management, and organizational skills.

•Ability to travel.

•Knowledge of good clinical practice (GCP) and FDA Code of Federal Regulations (21 CFR 11, 50, 56, 312, 812, 45 CFR 46). These are some of the documents that govern clinical trial conduct.

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