New

Regulatory Affairs Coordinator II

Massachusetts General Hospital
United States, Massachusetts, Boston
101 Merrimac Street (Show on map)
May 21, 2025
The Regulatory Affairs Coordinator (RAC) will work with investigators, study staff, Institutional Review Boards (IRBs), clinical trial sponsors and federal regulatory agencies to ensure that regulatory requirements are met for clinical trials. This role reports to the Regulatory Affairs Research Manager and works closely with research teams across the Cancer Center to ensure regulatory compliance for multiple cancer trials. Principal Responsibilities The following duties will be performed independently: Facilitate initial new trial submission for SRC and IRB review Develop the Informed Consent document for the clinical trial protocol with the input of the trial's sponsor and Principal Investigator Correspondence with the IRB, investigators, and sponsors throughout the review process Provide clinical trial sponsors with required regulatory documents during study initiation process Prepare and submit protocol amendments during the IRB review process Creation and maintenance of electronic regulatory binders Maintain a working knowledge of the IRB's current guidelines and forms for protocol and consent form submissions Specialize in certain disease groups, which includes maintaining study staff lists Please note that this is a remote role and there will be no physical office/location. Applicants may work in all states with the following exceptions: WY, ND, Puerto Rico, and the U.S. Virgin Islands. 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 Candidates with no relevant experience will be hired as a RAC I The General Hospital Corporation is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.