Clinical research associate
A clinical research associate (CRA), also called a clinical monitor or trial monitor, is a health-care
Overview
The main function of a clinical research associate is to monitor
Certification and practice
Canada
The Canadian Association of Clinical Research Specialists (CACRS) is a federally registered professional association in Canada (Reg. #779602-1).[6][7] The CACRS is a not-for-profit organization that promotes and advocates on behalf of its members in the field of Clinical Research and Clinical Trials. The CACRS has a comprehensive accreditation program including the Clinical Research Specialist (CRS) designation, which is a professional title conferred by passing a qualifying exam. Applicants holding a doctorate degree in medicine or science are required 2 years of prior experience whereas bachelor's degree holders are required 3 years of prior experience prior to taking the qualifying exam.[8]
European Union
In the European Union, the practice guidelines for CRAs are part of EudraLex.[citation needed]
India
In India, a CRA requires knowledge about New drugs and Clinical trials Rules, 2019.[citation needed]
United States
In the United States, the rules of good clinical practice are codified in
The Society of Clinical Research Associates (SOCRA) is a non-profit organization that is "dedicated to the continuing education and development of clinical research professionals".[11] The Society of Clinical Research Associates (SOCRA) has developed an International Certification Program in order to create an internationally accepted standard of knowledge, education, and experience by which CRPs will be recognized as Certified Clinical Research Professionals (CCRP®s) in the clinical research community. The standards upon which this certification program is based have been set forth by this organization to promote recognition and continuing excellence in the ethical conduct of clinical trials. SOCRA provides training, continuing education, and a certification program. A CRA who is certified through SOCRA's certification program receives the designation of a Certified Clinical Research Professional (CCRP®).[12]
The Association of Clinical Research Professionals (ACRP) provides a certification for CRAs, specific to the job function performed.
Accredited Programs
References
- ^ Prospects, Clinical research associate. Retrieved 28 April 2014.
- ^ McMaster University, Certified Clinical Research Associate. Retrieved 28 April 2014.
- ^ "Clinical Research Associate (CRA): A Day in the Life". Mhaonline.com. Retrieved 5 September 2021.
- ^ "What's it Like to be a Site Monitor? A Day in the Life, as Reported by a Top-tier CRA". Clinical Research IO. Retrieved 13 September 2018.
- ^ a b Clinical Research Training Online, Inc. What is a CRA? Archived 1 June 2012 at the Wayback Machine
- ^ Canadian Association of Clinical Research Specialists Archived 25 April 2012 at the Wayback Machine
- ^ Corporations Canada, Federal Corporation Information - 7796021
- ^ Octavian. "CACRS. – Canadian Association of Clinical Research Specialists". Retrieved 21 March 2019.
- ^ "Code of Federal Regulations - Title 21 - Food and Drugs". www.gpo.gov/. Office of the Federal Register National Archives and Records Administration. Retrieved 30 July 2014.
- ^ CNNMoney, Best Jobs in America: 4. Clinical Research Associate.
- ^ Society of Clinical Research Associates
- ^ Society of Clinical Research Associates, Certification Program Overview.
- ^ "Association of Clinical Research Professionals". Archived from the original on 24 July 2011. Retrieved 20 January 2011.
- ^ a b c d Association of Clinical Research Professionals, Eligibility for the CCRA Program. Archived 2 December 2013 at the Wayback Machine
- ^ "How To Become A Clinical Research Associate". Clinical Research Training. Retrieved 28 December 2018.
- ^ "National Commission for Certifying Agencies". Archived from the original on 16 September 2016. Retrieved 28 April 2014.
External links
- Association of Clinical Research Professionals (United States and United Kingdom)
- Certified Clinical Research Professionals (United States)
- Canadian Association of Clinical Research Specialists
- Clinical Research Association of Canada (Canada)
- Clinical Research Society - Certified Clinical Research Associate
- ICH Guidelines
- Society of Clinical Research Associates (United States)