Knoxville, TN30+ days ago
Documents and maintains all study-related procedures, processes and events by obtaining and reviewing original source documents (e.g., office notes, scans, tests, procedure results), abstracting data to study forms and flowsheets, recording accurate and timely data into electronic or hard copy case report forms, documenting protocol deviations and exemptions, planning and designing new forms/source document tools to be used in protocol implementation and resolving data queries- amending case report forms as appropriate. Manages clinical trials patient by scheduling all protocol required tests, physician and nurse assessment visits, monitoring patients' 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 System IRB according to protocol guidelines, manages/resolves complex patient/physician/clinical trial issues without supervision.