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.
Minimum Requirements:
- Requires an associate's degree and six years of research experience
- A bachelor's degree may substitute 2 years of required experience
Preferred Qualifications:
- Previous experience with Duke Clinical Research systems including OnCore, iRIS, eREG, CQMP and maestrocare.
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 requirements, develops and implements operational and closeout plans, and oversees processes that support efficient study execution, participant management, and successful completion of research activities across multiple studies and sites.
Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $70,749.00 to USD $112,871.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.
Your total compensation goesbeyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/
