Regulatory Affairs Coordinator - Cancer Center Protocol Office-(3302443)
Description
General Summary :
The Regulatory Affairs Coordinator (RAC) will work with investigators, sponsors, Institutional Review Boards (IRB) and research support staff 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 and MGB hospitals to ensure regulatory compliance for multiple trials.
Detailed Responsibilities include managing the following for multiple studies :
- 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
Please note that this is a remote role and there will be no work at the physical office / location. Applicants may work in all states with the following exceptions : WY, ND, Puerto Rico, and the . Virgin Islands.
Qualifications
Qualifications
- BA / BS required
- Detail-orientation with the ability to manage multiple projects simultaneously
- Strong organizational skills
- Excellent oral and written communication skills
- Prior regulatory or clinical research experience with an academic medical center or industry a plus
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