Senior Clinical Trial Manager overseeing site management and monitoring for biopharmaceutical solutions organization. Responsible for clinical monitoring, patient safety, and regulatory compliance in South Africa.
About the role
- Clinical Research Coordinator, Sr advancing federally funded and industry-sponsored neonatal and perinatal research at Duke. Overseeing regulatory compliance and mentoring research staff in a medical center.
Responsibilities
- 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
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