Clinical Research Coordinator III
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Description
POSITION SUMMARY:
The Clinical Research Coordinator III (CRC 3) is a senior-level clinical research professional responsible for independently coordinating and managing complex clinical research studies while ensuring compliance with regulatory, protocol, and institutional requirements. In addition to overseeing study conduct and participant management, the CRC 3 serves as a team leader and subject matter expert who contributes to process improvement initiatives and supports the development of high-quality clinical research operations across the department.
CORE ESSENTIAL RESPONSIBILITIES:
- Independently coordinate and manage clinical research studies from participant screening and enrollment through study completion.
- Assess potential research participants for protocol eligibility in collaboration with Principal Investigators and study teams.
- Obtain and document informed consent and ensure ongoing compliance with protocol requirements and institutional policies.
- Coordinate and conduct study visits, including specimen collection, processing, storage, shipment, and documentation.
- Collect, enter, maintain, and validate clinical research data within study databases and data collection systems.
- Collaborate with regulatory personnel to ensure all required regulatory documents are current, complete, and maintained appropriately.
- Maintain compliance with Good Clinical Practice (GCP), HIPAA, sponsor requirements, and applicable regulatory standards.
- Perform quality assurance and quality control activities to ensure accuracy, completeness, and audit readiness of assigned studies.
- Develop study tools, source documentation, workflows, and training materials that support effective research operations.
- Communicate and collaborate with investigators, sponsors, monitors, and multidisciplinary teams to support successful study execution.
- Identify and support new clinical research opportunities through interactions with sponsors and research stakeholders.