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Obtain detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study.
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Under the ultimate responsibility of the Principal Investigator (PI) and in close collaboration with the clinical/medical officer assigned to the study, the manager will manage day-to-day clinical research operations; study coordination duties, from protocol development/initiation to study close-out, according to regulatory/sponsor guidelines; and assure study integrity throughout.
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Notifies Screening Nurse of any vital sign, ECG or laboratory parameters that may exclude volunteer from study. Attends protocol training meetings to review specimen processing requirements and ensures availability of supplies needed.
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Pre-screens electronic medical records (EMR), surgical schedules, etc., for potential research/data collection candidates to determine if they qualify and meet protocol for specific study or registry.
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Adheres to all medical responsibilities according to the study protocol, Standard Operating Procedures (SOPs), Clinical Operating Procedures (COPs), International Conference on Harmonization Good Clinical Practice (ICH GCP), and local regulations.
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Significant experience with cross-functional leadership and clinical teams, including leading data review, protocol deviation review, database lock, CSR development, and study reporting activities.
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This role will operate under the Protocol Activation Supervisor and will serve as project manager for an assigned study portfolio, providing a high level of technical and regulatory expertise and guidance to research faculty and staff and tumor site teams in accordance with the current Food and Drug Administration (FDA) regulations/guidance and MCI/BHSF policy.
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Reviews protocol and provides study feasibility input to the NCH-RI Leadership and Study Start-up Team. Works with QI/QA team to ensure quality standards are being met and reports adverse events, protocol deviations.
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