Regulatory Coordinator overseeing compliance for oncology clinical trials at Duke Cancer Institute. Leading regulatory operations and mentoring staff to support cancer research initiatives.
Responsibilities
Oversee regulatory submissions and documentation for clinical trials
Ensure compliance with institutional, federal, and sponsor requirements
Lead and mentor a team of regulatory professionals
Collaborate with sponsors, CROs, and internal stakeholders to resolve regulatory and safety issues
Manage compliance with institutional policies, NIH Public Access, ct.gov, and Research Data Security Plans
Lead safety reporting, including timely submission of Adverse Event Reports per institutional and sponsor guidelines
Supervise and develop staff, providing coaching, performance reviews, and career development opportunities
Prepare for audits and monitoring visits, addressing findings and ensuring corrective actions
Requirements
Associate’s degree required
Bachelor’s degree strongly preferred
Six years of research or regulatory experience
Specific Regulatory experience required: Experience with industry sponsors and CROs; Proven ability to manage a large, complex portfolio (30+ therapeutic studies)
Completion of the DOCR Clinical Research Apprenticeship may substitute for one year
A Bachelor’s degree may substitute for two years of experience
Oncology experience preferred
Academic clinical research experience strongly preferred
Benefits
Comprehensive and competitive medical and dental care programs
Generous retirement benefits
Wide array of family-friendly and cultural programs
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