Duke University · 2 weeks ago
Regulatory Coordinator, Senior - Duke Cancer Institute
Durham, NC
Full-time
Onsite
Senior Level
$69K/yr - $111K/yr
6+ years expDuke University is a leading academic medical center, and the Duke Cancer Institute’s Oncology Clinical Research Unit is seeking a Regulatory and Safety Operations Lead. This role involves leading regulatory and safety operations for oncology clinical trials, ensuring compliance and supporting groundbreaking cancer research that impacts patient care.
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Responsibilities
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
Qualification
Required
Associate's degree
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
Preferred
Bachelor's degree
Recognized expertise in regulatory submissions for complex therapeutic studies
Two years of management experience (training, mentoring, accountability)
Experience working with industry sponsors and CROs
Oncology experience
Benefits
Comprehensive and competitive medical and dental care programs
Generous retirement benefits
Wide array of family-friendly and cultural programs
Company
Duke University
Duke University is a private research university providing undergraduate and postgraduate education in medicine and other disciplines.
10001+ employees
H1B Sponsorship
Duke University has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (274)
2024 (232)
2023 (202)
2022 (195)
2021 (148)
2020 (121)
Funding
Current Stage
Late StageTotal Funding
$71.15MKey Investors
North Carolina Biotechnology CenterUS Department of EnergyGlaucoma Research Foundation
2023-02-17Grant· $0.11M
2022-09-19Grant
2022-03-09Grant· $0.05M
Leadership Team
Barry Myers
Professor and Director
Dan Ariely
Professor
Recent News
2026-01-11
2025-12-18
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