Clinical Study Specialist Job at Regeneron, Cambridge, MA

  • Regeneron
  • Cambridge, MA

Job Description

Regeneron seeks a Clinical Study Specialist to provide technical and administrative support to clinical trial teams. The role involves managing study timelines, coordinating with sites and stakeholders, tracking enrollment and monitoring activities, and ensuring regulatory compliance across multiple trial programs.

Responsibilities

  • Generate reports, metrics, and coordinate study team meetings and documentation
  • Assess feasibility, support site selection, and review clinical trial documents
  • Track site activation, enrollment, and monitoring visits against project timelines
  • Ensure timely receipt of regulatory reports and perform TMF reconciliations
  • Support study close-out activities and maintain site relationships

Requirements

  • Bachelor's degree with 2+ years of clinical industry work experience
  • Proficiency in trial management systems, MS Office (Project, PowerPoint, Word, Excel)
  • Working knowledge of IVRS/IWRS, EDC, and TMF platforms
  • Basic familiarity with medical terminology and clinical drug development
  • Awareness of ICH/GCP guidelines
  • Strong organizational skills and ability to manage competing deadlines

Compensation: $93,900-$153,300 base

Job Tags

Work experience placement

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