Senior Regulatory Coordinator
Duke Careers
full-time
Posted on:
Location Type: Hybrid
Location: Durham • North Carolina • 🇺🇸 United States
Visit company websiteSalary
💰 $69,362 - $110,658 per year
Job Level
Senior
About the role
- 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.
Requirements
- 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.
- 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 to eligible team members.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionsprotocolssafety reportsadverse event reportingcomplianceNIH Public Access policyct.govResearch Data Security Plansstudy-level documentationenrollment logs
Soft skills
leadershipmentoringcoachingperformance reviewsprofessional developmentcollaborationcommunicationmotivationcreativityteam culture
Certifications
Associate’s degreeBachelor’s degreeDOCR Clinical Research Apprenticeship