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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.
The site is usually a hospital or a similar health care institution that has adequate infrastructure and staff to meet the requirements of the clinical trial protocol. The scope of an SMO's responsibility is limited to the site and hence the eponymous title. Some (but not all) of the responsibilities include: Contract
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 monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial.Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) [1] and the World Health Organization (WHO), [2] require data and safety monitoring protocols for Phase I and II clinical trials ...
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:
Job profile acceptable in CDM: clinical researcher, clinical research associate, clinical research coordinator etc. The clinical data manager plays a key role in the setup and conduct of a clinical trial. The data collected during a clinical trial form the basis of subsequent safety and efficacy analysis which in turn drive decision making on ...
Patient recruitment is the process of finding and enrolling suitable participants for clinical trials. It is a crucial aspect of drug development and medical research, as it affects the validity, reliability, and generalizability of the results.
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