Massachusetts General Hospital · 2 days ago
Regulatory Affairs Coordinator - Cancer Center Protocol Office
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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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Required
BA/BS required
Detail-orientation with the ability to manage multiple projects simultaneously
Strong organizational skills
Excellent oral and written communication skills
Preferred
Prior regulatory or clinical research experience with an academic medical center or industry a plus
Company
Massachusetts General Hospital
Massachusetts General Hospital is a primary teaching hospital of Harvard Medical School and a biomedical research facility.
Funding
Current Stage
Late StageTotal Funding
$97.11MKey Investors
Hyundai Hope On WheelsCVSPharmacyLunder Foundation
2024-08-28Grant· $0.4M
2023-08-11Grant· $1.6M
2023-02-27Grant· Undisclosed
Leadership Team
Recent News
2024-11-06
2024-11-06
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