Knoxville, Tennessee30+ days ago
Documents and maintains all study-related procedures, processes, and events by obtaining and reviewing original source documents, i.e., office notes, imaging reports, lab reports, procedure notes, etc.), abstracting data to study forms and flowsheets, recording accurate and timely data entry into electronic or hard-copy case report forms, documenting protocol deviations and exemptions, planning and designing new forms/source document tools to utilize in protocol implementation. Manages clinical trial patient by scheduling all protocol-required tests, physician and nurse assessment visits, monitoring patient’s response to protocol treatment, accompanying the physician for all protocol-required visits at all offices, reporting all serious adverse effects to the appropriate agency and Covenant Health IRB according to protocol guidelines, manages/resolves complex patient/physician/clinical trial issues without supervision.