Massachusetts General Hospital · 2 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.

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

Additionally, this role will support high priority Phase I oncology trials utilizing an expedited review pathway

Qualification

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Regulatory AffairsClinical TrialsInformed Consent DocumentsProject ManagementRegulatory Documents SubmissionClinical Research Experience