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A clinical research associate (CRA), also called a clinical monitor or trial monitor, is a health-care professional who performs many activities related to medical research, particularly clinical trials. Clinical research associates work in various settings, such as pharmaceutical companies, medical research institutes and government agencies.
Clinical monitors execute the monitoring plan laid out by the sponsors and investigators of a clinical trial. Monitors may be referred to by many different titles, such as: Clinical Research Associate, "on-site" monitor, Clinical Research Monitor, Study Site Monitor and Quality Specialist. The number of clinical monitors depends on the scale ...
A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice [1] (GCP) under the auspices of a Principal Investigator (PI). Good clinical practices principles have been defined by Madelene Ottosen, RN, MSN, of The University of Texas Health Science Center at Houston [ 2 ] as:
GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of institutional review boards, clinical research investigators, clinical trial sponsors, and monitors. In the pharmaceutical industry monitors are often called clinical research associates.
Research associates are researchers (scholars and professionals) that usually have an advanced degree beyond a Bachelor's degree such as a master's degree or a PhD.. In some universities/research institutes, such as Harvard/Harvard Medical School/Harvard School of Public Health, [1] the candidate holds the degree of Ph.D. or possess training equivalent to that required for the Ph.D.
Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. [1] Clinical data management ensures collection, integration and availability of data at appropriate quality and cost.
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