Regulatory Affairs Coordinator - Cancer Center Protocol Office @ Massachusetts General Hospital | Jobright.ai
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Regulatory Affairs Coordinator - Cancer Center Protocol Office jobs in Boston, MA
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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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Regulatory AffairsClinical TrialsInformed Consent DocumentsProject ManagementRegulatory Documents SubmissionClinical Research Experience

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

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Massachusetts General Hospital is a primary teaching hospital of Harvard Medical School and a biomedical research facility.

Funding

Current Stage
Late Stage
Total Funding
$97.11M
Key Investors
Hyundai Hope On WheelsCVSPharmacyLunder Foundation
2024-08-28Grant· $0.4M
2023-08-11Grant· $1.6M
2023-02-27Grant· Undisclosed

Leadership Team

E
Elizabeth Mort
Senior Vice President Quality & Safety, Chief Quality Officer
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Andrew Cole
Chief & Division of Clinical Neurophysiology
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