Clinical Data Manager-Ii (Research Data Coordinator)
CurrentClosely work with the principal investigator, study staff and monitors to ensure quality data, and will assist the principal investigator in achieving data integrity and study objectives through the successful implementation and completion of protocol data requirements.Assess the study protocol for clarity and subject safety, review inclusion/exclusion criteria, and clarify questions and concerns with the principal investigator and sponsor.Obtain study patients’ medical history and demographics; maintain subject log as well as subject’s source documentation (including historical data, status reports, progress notes, laboratory and imaging results).Report and track adverse events; report serious adverse events to the sponsor, IRB, and to the Data and Safety Monitoring CommitteeEnter study data into case report forms (CRF); maintain a current and accurate study CRF database; and complete, correct and submit CRFs to the study sponsor.Prepare and complete study-related documentation such as protocol worksheets, logs, procedural manuals, adverse event reports and progress reports.Confirm or verify protocol deviations, reconcile test article accountability at study close out and prepare reports for sponsor.Maintain data and documents as required by FDA guidelines.
