Clinical Study Specialist
Regeneron · Armonk +1 more
Clinical OperationsFull-time$94k–$153kCompany career page
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Role summary
Regeneron seeks a Clinical Study Specialist to provide technical and administrative support to clinical trial teams. The role involves coordinating study activities, tracking enrollment and site activation, managing documentation, and ensuring compliance from trial initiation through close-out.
What they're looking for
- Bachelor's degree with 2+ years clinical industry experience
- Proficiency with trial management systems and MS Office applications
- Working knowledge of IVRS/IWRS, EDC, and TMF systems
- Basic familiarity with medical terminology and drug development
- ICH/GCP awareness
- Strong organizational skills and deadline management
What you'll be doing
- Organize and deliver study reports, metrics, and coordinate team meetings and documentation
- Collate data for feasibility assessments and review study documents and regulatory materials
- Track site activation, enrollment, and monitoring visits; escalate delays or issues
- Ensure timely receipt of regulatory reports and perform TMF reconciliations
- Support study close-out activities and maintain site relationships and contact information
Privacy & handoff
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