Regulatory Coordinator, Senior - Duke Cancer Institute

Regulatory Coordinator, Senior - Duke Cancer Institute

Work Arrangement:
Hybrid (On-Site and Remote mix)

Requisition Number: 264475

Regular or Temporary:
Regular

Durham, NC, US, 27710

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 Duke Cancer Institute’s Oncology Clinical Research Unit (CRU) is seeking a Regulatory and Safety Operations Lead to join our Central Startup Activation Team (A-Team). In this role, you will lead day‑todie regulatory and safety operations for multiple, complex oncology clinical trials and research studies, including those involving Investigational Products (IP). Your work will ensure compliance, streamline processes, and support groundbreaking cancer research that impacts patient care.

• Direct and oversee regulatory submissions including consent forms, protocols, and continuing reviews to the IRB.
• Manage study‑level documentation such as regulatory binders, enrollment logs, patient registration, and safety reports.
• Ensure compliance with institutional requirements, NIH Public Access policy, ct.gov, and Research Data Security Plans.
• Lead and mentor staff
  , providing coaching, performance reviews, and fostering professional development.
• Collaborate with sponsors and CROs on regulatory and safety issues; prepare for audits and monitoring visits.
• Oversee adverse event reporting and ensure timely submission of safety documentation.
• Create a team culture that fosters open communication, motivates staff, and encourages creativity.

• Six years of research or regulatory experience.
• Completion of DOCR Clinical Research Apprenticeship may substitute for one year.
• Bachelor’s degree may substitute for two years of experience.

• Recognized expertise in regulatory submissions for complex therapeutic studies.
• Two years of management experience (training, mentoring, accountability).
• Experience working with industry sponsors and CROs.

Join a team that embodies Duke’s core value:
Cancer Care as It Should Be. At Duke Cancer Institute, you’ll work alongside leading experts in oncology research, contributing to studies that transform patient care. We offer a collaborative environment, professional growth opportunities, and access to Duke University’s competitive benefits package.

Duke University provides an annual base salary range for this position as USD $69,362.00 to USD $. 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 goes beyond 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 (Use the "Apply for this Job" box below)./

Job Code:  REGULATORY COORD, SR

Job Level: 53

Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression,…