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]] {{job-stub}} {{med-stub}} [[de:Klinischer Monitor]] [[ru:Специалист по клиническим исследованиям]]