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Manage day-to-day clinical trial activities, including participant recruitment, screening, enrollment, consent, study visits, protocol procedures, and retention. Prepare study documents, monitor participant safety, document study data, report adverse events, and coordinate financial reconciliation and trial closeout with investigators, sponsors, and hospital departments.
A Clinical Research Coordinator 1 (CRC 1) is a research professional who works under the guidance and supervision of their leader and is responsible for managing all the day-to day activities of clinical trials, including but not limited to, recruitment, screening, enrollment of participants, obtaining informed consent, conducting study visits and performing protocol required procedures as permitted by policy and delegated by the Principal Investigator. A CRC 1 focuses on ways to ensure retention of clinical trial participants; tracks all study visits, reviews and validates the accuracy of financial reports; works with Research Finance and Regulatory to reconcile all items necessary to close out completed clinical trials according to established federal regulations and guidelines. The CRC 1 prepares study specific source documents; continuously monitors the safety and rights of the participants, documents all required data in the sponsor's data capture tool and reports all adverse and serious adverse events that occur during the course of the trial to the Principal Investigator and the study sponsor. The CRC 1 works closely with the sponsor representatives and the Principal Investigator, as well as the ancillary departments within the Office of Clinical Research and with other departments/clinics within the hospital or hospital system. Responsible for performing job duties in accordance with mission, vision and values of Tampa General Hospital.
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