Regulatory Affairs Coordinator I

Center for Integration Science

Boston, MA, United States
Base: $20.16 - $29.01phly; bonus/equity: not speci...
Hybrid
Prepare and submit protocol amendments to irb
Revise informed consent documents for new risks
Manage adverse events and deviation documentation
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 preparing protocol amendments, revising informed consent documents, and managing adverse event reporting for enrolled patients.
  • Mass General Brigham offers competitive base pay ranging from $20.16 to $29.01 per hour along with comprehensive benefits and career advancement opportunities.

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, differentials, premiums, and bonuses

Skills & Requirements

Must-have

  • Prepare and submit protocol amendments to IRB
  • Revise informed consent documents for new risks
  • Manage adverse events and deviation documentation
  • Submit Data and Safety Monitoring Reports
  • Maintain source documentation of correspondence

Nice-to-have

  • Careful attention to detail in regulatory work
  • Strong organizational skills for study binders
  • Ability to follow complex federal regulations
  • Computer literacy for document management
  • Working knowledge of clinical research protocols

Key Requirements

  • Bachelor's Degree in Related Field of Study
  • Experience can substitute for degree requirement
  • Knowledge of clinical research protocols required

Work Rights

Not specified

Tailored Resume

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