Senior Clinical Research Coordinator
Duke Careers
full-time
Posted on:
Location Type: Office
Location: Durham • North Carolina • United States
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Salary
💰 $69,362 - $110,658 per year
About the role
- serve as an institutional expert in FDA, IND, and international regulatory requirements
- direct teams to appropriate Duke offices for contract execution and approval processes
- oversee investigational product (IP) management for multiple studies
- develop, optimize, and manage systems for specimen collection, processing, shipping, and storage across the research program
- lead preparation for monitoring visits, audits, and regulatory inspections
- provide advanced oversight and training for participant-level documentation
- guide teams in accurate identification, documentation, and reporting of adverse events
- select and implement data capture methods for multiple studies
- independently draft grant applications, study aims, and background sections for funding proposals
- mentor teams on communication with sponsors and CROs
Requirements
- minimum of six years of research experience
- Associate's degree or Bachelor's degree preferred
- mastery of FDA regulations, IND submissions, data governance, and international regulatory coordination
- ability to mentor staff and support high-impact research portfolios
Benefits
- comprehensive and competitive medical and dental care programs
- generous retirement benefits
- wide array of family-friendly and cultural programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
FDA regulationsIND submissionsdata governancespecimen collectiondata capture methodsgrant applicationsstudy designadverse event reportingregulatory inspectionscontract execution
Soft Skills
mentoringcommunicationteam leadershiptrainingorganizational skillsproblem-solvingcollaborationattention to detailproject managementstakeholder engagement
Certifications
Associate's degreeBachelor's degree