Regulatory Affairs Coordinator I

621

Boston, Massachusetts, United States
Base: $20.16 - $29.01phly; bonus/equity: not speci...
Hybrid
Prepare and submit protocol amendments to irb
Revise informed consent documents
Maintain study-specific regulatory binders
This position works under general supervision to ensure regulatory requirements for clinical trials are met at The Brigham and Women's Hospital

Job Summary

  • This position works under general supervision to ensure regulatory requirements for clinical trials are met at The Brigham and Women's Hospital.
  • The role involves collaborating with clinical teams, Institutional Review Boards, sponsors, and federal regulatory agencies to advance medical discoveries.
  • Candidates will be trained on institutional and federal regulations governing clinical research while managing essential regulatory documentation.

Matching Summary

This position works under general supervision to ensure regulatory requirements for clinical trials are met at The Brigham and Women's Hospital.

Salary

Base: $20.16 - $29.01/Hourly; Bonus/Equity: Not specified; Benefits: Comprehensive benefits, career advancement opportunities, differentials, premiums, and bonuses included

Skills & Requirements

Must-have

  • Prepare and submit protocol amendments to IRB
  • Revise informed consent documents
  • Maintain study-specific regulatory binders
  • Manage adverse events documentation
  • Submit Data and Safety Monitoring Reports

Nice-to-have

  • Careful attention to detail
  • Good organizational skills
  • Ability to follow directions
  • Computer literacy
  • Working knowledge of clinical research protocols

Key Requirements

  • Bachelor's Degree in Related Field of Study
  • Experience can substitute for degree requirement

Work Rights

Not specified

Tailored Resume

Cover Letter