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General Summary :
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 :
This includes sending annual reports to the FDA for dozens of studies, as well as communicating with the FDA about changes to studies and any adverse events that may occur.
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 U.S. Virgin Islands.
Qualifications
Candidates with no relevant experience will be hired as RAC I
Massachusetts General Hospital is an Affirmative Action 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.
Full Time
Ambulatory Healthcare Services
$75k-99k (estimate)
09/21/2023
04/10/2024
massgeneral.org
BOSTON, MA
7,500 - 15,000
1811
Private
CATHY E MINEHAN
$1B - $3B
Ambulatory Healthcare Services
Massachusetts General Hospital provides diagnostic and therapeutic care services.