Responsible for coordinating and performing study specific clinical and regulatory activities across multiple study protocols of different therapeutic areas and phases in accordance with appropriate regulations Standard Operating Procedures SOPs and study specific protocolsplans and processes Principal Accountabilities Coordinates and implements the assigned protocols and recruit subjects to collect data from patient charts medical records interviews questionnaires diagnostic tests and other sources Ensures compliance with protocol guidelines and requirements of regulatory agencies identifies problems andor inconsistencies and monitors patients progress to include documentation and reporting of adverse events and recommends corrective action as appropriate Coordinates the development of forms questionnaires and the application of research techniques assists in writing procedure manuals reviews journals abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in planning Develops appropriate regulatory reports and associated documentation in accordance with SOPs and study specific processes Performs periodic regulatory audits on department studies being coordinated by other coordinators Works closely with sponsor and study personnel on relevant safety and regulatory issues Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across studies and adapts to timeline or priority changes by reorganizing daily workload Performs other related duties as assigned
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