Clinical Study Specialist

Regeneron is hiring a Clinical Study Specialist to support clinical trial execution across multiple programs. The role involves coordinating study activities, managing data and reports, tracking enrollment and site status, and ensuring regulatory compliance from activation through close-out.

Responsibilities

• Generate analyzable reports and metrics; coordinate study team meetings and documentation
• Collate feasibility data and review study documents including informed consent and case report forms
• Track site activation, enrollment, and monitoring visits against timelines; escalate delays
• Verify timely receipt of regulatory reports and perform trial master file reconciliations
• Support study close-out activities and manage communications with clinical sites and vendors

Requirements

• Bachelor's degree with 2+ years clinical industry work experience
• Proficiency with trial management systems and Microsoft Office applications
• Working knowledge of IVRS/IWRS, EDC, and TMF systems
• Basic understanding of medical terminology and clinical drug development
• Familiarity with ICH/GCP guidelines
• Strong organizational skills and deadline management ability

Compensation: $93,900–$153,300 annually