Clinical research associate
2449402
220192502
2008-06-18T18:29:50Z
Blueoceancruiser
7333349
A '''clinical research associate''' ('''CRA''') is a [[profession]] defined by [[Good clinical practice]] guidelines ([[International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use|ICH]] GCP).
The main function of a clinical research associate is to monitor [[clinical trial]]s. 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 Form]]s ([[CRF]]s) 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]].
==External links==
*[http://www.socra.org/ Society of Clinical Research Associates (United States)]
*[http://www.acrpnet.org/ Association of Clinical Research Professionals (United States and United Kingdom)]
*[http://www.mpphase.com Freelance CRA Listing]
*[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]
[[Category:Clinical research]]
[[Category:Healthcare occupations]]
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[[de:Klinischer Monitor]]
[[ru:Специалист по клиническим исследованиям]]