Clinical research associate: Difference between revisions

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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 trials. He or she may work directly with the sponsor company of a clinical 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.

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 *[http://www.emissary.com/Focus-on-Clinical-Research-Professionals/supermonitor.html The Adventures of SuperMonitor - A Bedtime Story for the Young Clinical Research Associate, written by a CRA at Emissary International]
 *[http://www.crocareers.in Self Paced Clinical Research Training, Effective and Affordable]
+*[http://www.CRAforum.pl Forum dedicated for Polish Clinical Research Associates]