Clinical Research Coordinator, Sr

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.

The Children's Clinical Research Unit within the Department of Pediatrics is seeking an experienced Clinical Research Coordinator, Senior, to join our team. In this role, you will provide leadership and operational expertise across multiple study teams, supporting complex clinical research studies from startup through closeout. You will serve as a trusted resource for regulatory compliance, study operations, data quality, participant recruitment and retention, as well as research staff development.

• Requires an associate's degree and six years of research experience
• A bachelor's degree may substitute 2 years of required experience

• Previous experience with Duke Clinical Research systems including OnCore, iRIS, eREG, CQMP and maestro care.

This position is Onsite. The work is performed on-site or at a designated assignment location.

• Serves as a senior research operations and regulatory expert across multiple study teams, providing oversight, training, and strategic guidance on regulatory compliance, institutional policies, investigational product management, participant recruitment and retention, study documentation, specimen management, SOP development, and study conduct. Leads preparation for monitoring and audits, develops operational processes and tools, supports complex study visits and participant screening, facilitates cross-functional collaboration, and mentors staff to ensure high-quality research operations, effective communication, and achievement of study goals.
• Provides leadership, oversight, and training across multiple study teams to ensure compliance with adverse event reporting, informed consent processes, IRB submissions, and regulatory and safety reporting requirements. Serves as an expert resource for developing consent plans and documents, conducting and documenting informed consent for complex studies, navigating Duke research requirements, and ensuring regulatory submissions are accurate, timely, and compliant with institutional, sponsor, and regulatory expectations.
• Lead the department's Clinical Quality Management Program reviews and support compliance surveillance activities, including patient research billing, Medicaid attestation submissions, Human Subjects Protection and Good Clinical Practice (GCP) training compliance, and maintenance of key Duke research systems (e.g., iRIS and OnCore).
• Provides strategic oversight and leadership across multiple study teams in sponsor and CRO communications, site visit management, protocol and participant tracking systems, study feasibility assessments, resource allocation, and financial oversight. Ensures research operations are conducted in compliance with institutional…