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