GENERAL SUMMARY / OVERVIEW STATEMENT:
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 Associate Manager and works closely with research teams across the Cancer Center (but mainly the Thoracic team) to ensure regulatory compliance for multiple cancer trials.
Detailed Responsibilities include managing the following for multiple studies:
- Completion and submission of clinical trials amendments to the IRB. This includes large amendments to the Protocol and other study documents received from industry sponsors throughout the course of the study, as well as smaller amendments to keep documents and processes up-to-date
- 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 activation process for new trials
- Revisions and in some cases creation of informed consent documents
- Correspondence with the IRB, investigators and sponsors throughout the clinical trial process
- Preparation of annual progress reports for IRB renewal of ongoing studies
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: OH, WY, WA, ND, Puerto Rico, and the U.S. Virgin Islands.Qualifications QUALIFICATIONS:
Candidates with no relevant experience will be hired as RAC IEEO Statement
- 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
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.
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