The Role of the Clinical Research Coordinator in Multicenter Clinical Trials |
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| Authors: | Susan Pelke RN David Easa MD |
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| Affiliation: | Susan Pelke is program coordinator of the Research Centers in Minority Institutions Clinical Research Center, Kapiolani Medical Center for Women and Children, Honolulu, HI.;David Easa is Program Director of the Research Centers in Minority Institutions Clinical Research Center and Director of Neonatology, Department of Pediatrics, Kapiolani Medical Center for Women and Children, Honolulu, HI. |
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| Abstract: | The clinical research coordinator plays a crucial role in organizing a site's participation in the expanding arena of multicenter medical and pharmacologic clinical trials. This summary clarifies the role of the clinical research coordinator for inexperienced staff members assuming these responsibilities and outlines planning procedures leading to successful implementation. Emphasis is placed on establishing an interdependent relationship with the principal investigator, careful protocol assessment, team building, and staff feedback. Useful tools such as study manuals and physicians' study orders are described. |
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