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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.
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:
A Site Management Organization (SMO) is an organization that provides clinical trial-related services to a contract research organization (CRO), a pharmaceutical company, a biotechnology company, a medical device company, or a clinical site.
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.
Responsibility for data and safety monitoring depends on the phase of the study and may be conducted by sponsor or Contract research organization (CRO) staff or contractor, and/or by the Principal clinical investigator/project manager conducting the study. Regardless of the method used, monitoring must be performed on a regular basis.
A clinical research assistant or clinical research associate is employed by a hospital or medical research centre, who is involved in the administration of clinical trials. They may assist a senior investigator with recruiting and enrolling research subjects, as well as with correspondence and grant applications.
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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 ...
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