A
clinical research associate (CRA) is a profession defined by Good clinical practice guidelines (ICH GCP).
The main function of a
clinical research associate is to monitor
clinical research trials. He or she may
work directly with the sponsor company of a
clinical research trial, as an independent freelancer or for a
Contract Research Organization (CRO). A clinical research associate ensures compliance with the
clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms
(CRFs) and communicates with
clinical research investigators. A
clinical research associate is usually
required to possess an academic degree in Life Sciences and needs to have a good knowledge of Good clinical
practice and local regulations. In the United States, the rules are codified in Title 21 of the Code of
Federal Regulations. In the European Union these guidelines are part of EudraLex.
Clinical research associates come from a wide variety of backgrounds with even more varied job descriptions.
Some
clinical research associates are MDs, while other are RNs, some may have a degree in medical
technology, business administration, health information management, statistics, biology, teaching, or
other areas. Every one of these backgrounds brings special areas of expertise to the
clinical research field.
Much of the training comes after employment as a
clinical research associate. Every institution and
discipline have unique requirements.
A
clinical research associate may serve as a clinical investigator, sub-investigator, clinical researcher,
research nurse, administrator, coordinator, data manager, project manager, IRB coordinator, Quality
Assurance specialist, regulatory affairs specialist, research pharmacist, consultant, or educator in
clinical research trials management. A
clinical research associate is involved in one or more aspects of
clinical trials (GCP) research, including data collection, analysis, or monitoring; case management of
protocol participants; recruitment and enrollment of human subjects; protection of subjects and subjects'
rights through IRB relations; development of informed consent documents; preparation of adverse event
experience reports; construction or monitoring of case report forms; maintenance of drug accountability
records; grant and budget development; report preparation; education of other health-care professionals,
patients or families regarding clinical trials, protocol development, program administration; and
clinical research program audit.
