CLINICAL RESEARCH COORDINATOR

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

 

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

 

Occupational Summary

The Department of Family Medicine and Community Health at the Duke School of Medicine seeks a Clinical Research Coordinator (CRC) to manage multiple studies and support faculty investigators in clinical, community-engaged, and population health research. As a central resource, the CRC will coordinate study execution from development to close-out, ensuring regulatory compliance, participant engagement, data management, and reporting across qualitative, quantitative, and mixed-methods research in clinical, community, and health system settings.

 

The ideal candidate is an organized problem-solver with strong project management skills, experience managing multiple studies, and cultural competence. They should demonstrate adaptability and a commitment to inclusive, ethical research.

Clinical Research Operations (35%)

Study Development & Regulatory Compliance

• Assist investigators in study design and protocol development, ensuring feasibility and regulatory alignment.
• Draft and submit IRB protocols, amendments, and study-specific SOPs in compliance with institutional and federal regulations.
• Facilitate necessary agreements (e.g., MTAs, CDAs) in coordination with institutional offices.
• Develop study workflows, training materials, and manuals to ensure consistency across study teams.
• Ensure adherence to Good Clinical Practice (GCP), HIPAA, and participant safety guidelines.

Study Implementation & Coordination

• Oversee recruitment and retention strategies, addressing barriers to participation and optimizing engagement.
• Screen, schedule, and consent participants in clinical, behavioral, and intervention-based studies.
• Ensure proper execution of randomization, blinding, and intervention procedures where applicable.
• Conduct participant visits, structured interviews, and data collection activities in adherence to protocols.
• Train and oversee study staff in study procedures, data collection, and participant interaction.

Study Management & Quality Control

• Maintain study documentation and ensure compliance with protocol and institutional policies.
• Track study milestones, proactively identify