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. In India he / she requires knowledge about schedule Y amendments in drug and cosmetic act 1945.
The Association of Clinical Research Professionals [1] (ACRP) provides a certification, specific to the job function one actually performs, for CRAs. ACRP offers the only accredited* CRA designation in the field, the Certified Clinical Research Associate (CCRA®).