Plan, direct, or coordinate clinical research projects. Direct the activities of workers engaged in clinical research projects to ensure compliance with protocols and overall clinical objectives. May evaluate and analyze clinical data.
<ul><li>Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.</li><li>Oversee subject enrollment to ensure that informed consent is properly obtained and documented.</li><li>Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.</li><li>Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.</li><li>Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, or discussions with physicians and nurses.</li><li>Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.</li><li>Prepare study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.</li><li>Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts, such as protocol revisions.</li><li>Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.</li><li>Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, or potential subject risks.</li><li>Code, evaluate, or interpret collected study data.</li><li>Participate in preparation and management of research budgets and monetary disbursements.</li><li>Participate in the development of study protocols including guidelines for administration or data collection procedures.</li><li>Instruct research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.</li><li>Communicate with laboratories or investigators regarding laboratory findings.</li><li>Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.</li><li>Order drugs or devices necessary for study completion.</li><li>Confer with health care professionals to determine the best recruitment practices for studies.</li><li>Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.</li></ul>