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Regulatory Affairs Coordinator - MGH Cancer Center Protocol Office at Massachusetts General Hospital (MGH) in Boston, Massachusetts

Posted in Other 11 days ago.

Type: Full Time





Job Description:

The Regulatory Affairs Coordinator (RAC) will work with investigators, study staff, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies to ensure that regulatory requirements are met for clinical trials. This role reports to the Regulatory Affairs Project/Program Manager and works closely with research teams across the Cancer Center to ensure regulatory compliance for multiple cancer trials.

Detailed Responsibilities include managing the following for multiple studies:

- Preparation and submission of clinical trials to the IRB.

- Correspondence with the IRB, investigators and sponsors throughout the review process

- Tracking and facilitating the progress of new trials through 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 regulatory binders and other relevant files during the approval process

- Creation of informed consent documents

- BA/BS required

- Prior regulatory or clinical research experience with an academic medical center or industry preferred

- Detail-orientation with the ability to manage multiple projects simultaneously

- Strong organizational skills

- Excellent oral and written communication skills

- Candidates with no relevant experience will be hired as RAC I

*NOTE: This position will be remote for the time being

Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.