Clinical Research Coordinators
Code: 11-9121.01
Description : 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.
JobTitles : Clinical Research Coordinator, Clinical Trial Manager, Clinical Program Manager, Clinical Research Associate (CRA), Clinical Research Nurse Coordinator, Clinical Program Coordinator, Clinical Research Administrator, Clinical Research Manager, Clinical Trial Coordinator, Research Coordinator
Tasks:
- Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
- Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
- Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
- Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
- Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
- 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.