Plans, directs, or coordinates clinical research projects. Directs the activities of workers engaged in clinical research projects to ensure compliance with protocols and overall clinical objectives. May evaluate and analyze clinical data.
This career is part of the Health Science cluster Support Services pathway.
A person in this career:
- Maintains required records of study activity including case report forms, drug dispensation records, or regulatory forms.
- Oversees subject enrollment to ensure that informed consent is properly obtained and documented.
- Monitors study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
- Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies.
- Assesses eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
- Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
- Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions.
- Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
- Tracks enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
- Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.