Massachusetts General Hospital · 5 days ago

Regulatory Affairs Coordinator - Cancer Center Protocol Office

Boston, MA

Full-time

Remote

Entry Level

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Responsibilities

Preparation and submission of clinical trials to the local and central IRB(s).

Creation and extensive revisions of informed consent documents

Tracking and facilitating the progress of new trials through the review process

Correspondence with the IRB of record, investigators, and sponsors throughout the review process

Collection, completion, and submission of regulatory documents to various regulatory entities. This includes collecting signatures and information from participating investigators and providing them to industry sponsors.

Creation and maintenance of electronic regulatory binders and other relevant files during the approval process

In addition to the above, this role will be submitting institution-sponsored studies to the FDA and maintaining the records with the FDA across the life of the study. This includes sending annual reports to the FDA for dozens of studies, as well as communicating with the FDA about changes to studies and any adverse events that may occur.

Qualification

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Regulatory AffairsClinical ResearchFDA Submission Process