Research Regulatory Specialist

Center for Integration Science

Boston, MA, United States
Base: $63,252.80 - $102,596.00 annually; bonus/equ...
Hybrid
Ich good clinical practice knowledge
Irb submission and review process
Ind/ide submission management
The position ensures all regulatory documentation is accurately prepared, maintained, and submitted following ICH GCP, FDA, and IRB guidelines

Job Summary

  • The position ensures all regulatory documentation is accurately prepared, maintained, and submitted following ICH GCP, FDA, and IRB guidelines.
  • This role guides investigators through the IRB review process and assists with the development of study documents including protocols and informed consent forms.
  • Mass General Brigham offers comprehensive benefits, career advancement opportunities, and a competitive base pay range based on qualifications.

Matching Summary

The position ensures all regulatory documentation is accurately prepared, maintained, and submitted following ICH GCP, FDA, and IRB guidelines.

Salary

Base: $63,252.80 - $102,596.00 annually; Bonus/Equity: Not specified; Benefits: Comprehensive benefits, career advancement, differentials, premiums, and bonuses included.

Skills & Requirements

Must-have

  • ICH Good Clinical Practice knowledge
  • IRB submission and review process
  • IND/IDE submission management
  • Protocol document preparation
  • 3-5 years regulatory experience

Nice-to-have

  • Excellent written communication skills
  • Ability to work independently
  • Strong time management skills
  • Experience in academic medical center
  • Proactive problem-solving abilities

Key Requirements

  • Bachelor's degree in related field required
  • Master's degree preferred
  • 3-5 years prior regulatory or clinical research experience
  • No experience accepted in lieu of degree

Work Rights

Not specified

Tailored Resume

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