Regulatory Coordinator - Duke Cancer Institute

Regulatory Coordinator Responsibilities

• Manage regulatory operations for complex oncology studies by preparing, submitting, and maintaining FDA, IRB, and institutional documentation in collaboration with Principal Investigators, ORAQ, sponsors, and internal stakeholders.
• Ensure compliance and audit readiness by maintaining complete regulatory binders, supporting monitoring and audit visits, responding to findings, and implementing corrective actions.
• Coordinate study and site management activities, including site initiation, monitoring, closeout, document storage, and sponsor/CRO communication using OnCore and eREG systems.
• Apply and interpret regulatory, institutional, and federal requirements, including support for international studies, to protocols, consent documents, SOPs, and operational plans.
• Contribute to team leadership and training by mentoring peers, developing tools or resources, leading multidisciplinary meetings, and supporting process improvement initiatives.

• Associate's degree.
• Minimum of two (2) years of research or regulatory experience in a clinical research setting. Completion of the DOCR North Carolina state‑approved Clinical Research Apprenticeship Program may substitute for one year of experience.

• Prior experience in oncology clinical trials.
• Experience supporting complex, interventional, or investigator‑initiated studies.
• Familiarity with FDA regulatory submissions and IRB processes.
• Experience working with industry sponsors and/or CROs.

• Proficiency with clinical research management systems (e.g., OnCore, eREG, iRIS).
• Strong written and verbal communication skills.

Annual base salary range: USD $59,829.00 to USD $99,960.00. Additional compensation includes comprehensive medical and dental benefits, retirement benefits, and family‑friendly programs.

Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: DAAS; phone: ).

Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, (including pregnancy and pregnancy‑related conditions), sexual orientation, or military status.