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Research Regulatory Specialist

Massachusetts General Hospital
United States, Massachusetts, Boston
125 Nashua Street (Show on map)
Sep 11, 2025
Will guide investigators in the IRB review process and will assist with the preparation and submission of protocol documents to the IRB and other regulatory committees to ensure regulatory compliance.
Does this position require Patient Care?
No
Essential Functions
-
The preparation and submission of protocols to the IRB
-Assists with development of study documents including protocols and informed consent forms
-Advising researchers and research teams on the regulatory review process
-Tracking and facilitating the progress of new trials through the review process
-Maintain working knowledge of current regulations and MGB IRB policies and guidance's
-Facilitate training for the research teams on changes to regulatory process or new regulatory requirements
-Track protocol status and alert Investigators and management team of regulatory actions required

Job Description
Education
Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred

Can this role accept experience in lieu of a degree?
No

Licenses and Credentials

Experience
Prior regulatory or clinical research experience with an academic medical center or industry 3-5 years required and

Knowledge, Skills and Abilities
- High level time management and organization skills.
- Excellent written and verbal communication skills.
- Knowledge of current and developing clinical research trends.
- Sound interpersonal skills.
- Ability to work independently and display initiative.
- Ability to identify problems and develop solutions.


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.
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