What Is a CRA?


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 monitors or clinical monitors. 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 CRAs

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
    • 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.

One note to mention is that CROs are sensitive to the economic cycles. When the economy is good, CROs may hire a lot of CRAs to meet the higher numbers of clinical trial demands. When the economy is bad, CROs may turn around and lay off CRAs as work demand reduces.

In addition, CRAs who work for a CRO are expected to work hard. They may be assigned to oversee multiple studies with high number of sites (>10 sites). That being said, 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 gaining exposure to a variety of therapeutic areas that may enhance a CRA’s credential and career progression.

Author

Post author

Ernie Sakchalathorn

Polachai Ernie Sakchalathorn is the founder of ClinicalResearchAssociateCRA.com and has been in clinical research since 2007. While he is no longer affiliated with the website or benefits financially from site operations, he still remains a professional in the clinical research space and currently serves as a Clinical Affairs Manager at a medical device company.

Leave a Reply

Your email address will not be published. Required fields are marked *