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Regulatory Document Reviewer

Employment Type Contract
Field of Work Clinical/Medical

 

Required Skills and Competencies

  • Strong medical background (Nursing experience preferred)
  • Strong Site Clinical Research background (e.g. Study Coordinators/Site Manager past roles)
  • Strong knowledge of the clinical trials process
  • Strong knowledge of the ICH/FDA/HIPAA regulations
  • Strong interpersonal oral & written communication skills
  • Prior experience review/direct approval of all essential regulatory documents
  • Ability to work in numerous Sponsor IT systems
  • Ability to work independently, with directed managerial oversight
  • Prior experience writing ICFs
  • Ability to write based on audience (e.g., pediatric, psychiatric trials, etc.)
  • Excellent spelling, grammar and punctuation, proof reading; format structure
  • Proficient with WORD
  • Good knowledge base of medical terminology
  • Preferred experience in CNS and oncology
  • Ability to work in a team environment or independently as needed
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