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Regulatory Affairs Specialist

2 months ago

Boston, Massachusetts, United States Mass General Brigham Full time
Regulatory Affairs Coordinator Job Description

We are seeking a highly organized and detail-oriented Regulatory Affairs Coordinator to join our team at Mass General Brigham. The successful candidate will work closely with investigators, sponsors, and research support staff to ensure regulatory requirements are met for clinical trials.

Key Responsibilities:
  • Manage the preparation and submission of clinical trials to local and central IRBs.
  • Create and revise informed consent documents to ensure compliance with regulatory requirements.
  • Track and facilitate the progress of new trials through the review process, ensuring timely submission and approval.
  • Correspond with IRBs, investigators, and sponsors to address any questions or concerns.
  • Collect, complete, and submit regulatory documents to various regulatory entities.
  • Develop and maintain electronic regulatory binders and other relevant files during the approval process.
  • Support high-priority Phase I oncology trials utilizing an expedited review pathway.
Requirements:
  • Bachelor's degree required.
  • Detail-oriented with the ability to manage multiple projects simultaneously.
  • Strong organizational skills and excellent communication skills.
  • Prior regulatory or clinical research experience preferred.
What We Offer:

Mass General Brigham is an Affirmative Action Employer and is committed to diversity, equity, and inclusion. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.