Regional Regulatory Manager ensuring environmental compliance for chemical distribution across Northeast US. Leading initiatives, audits, and reporting while providing strategic training and oversight.
About the role
- 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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