Clinical Research Regulatory Coordinator II

Mass General Brigham (Enterprise Services)
United States, Massachusetts, Boston
101 Merrimac Street (Show on map)
Nov 14, 2025
PRINCIPAL DUTIES AND 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 Provide clinical trial sponsors with required regulatory documents during study initiation process Prepare and submit protocol amendments during the IRB review process Create electronic regulatory binder 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 SKILLS/ABILITIES/COMPETENCIES REQUIRED: Ability to work independently and as a team member Careful attention to detail Computer literacy Analytical skills and ability to resolve problems Excellent oral and written communication skills Strong interpersonal skills Strong organizational skills Education Bachelor's Degree Healthcare Management required or Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? No Licenses and Credentials Experience Regulatory Affairs Experience 2-3 years required Knowledge, Skills and Abilities - Familiarity with Good Clinical Practice (GCP) guidelines and relevant regulations (e.g., ICH E6, 21 CFR, etc.). - Understanding of the clinical trial process and the importance of regulatory compliance in protecting research subjects and ensuring data integrity. - Strong organizational skills with attention to detail and the ability to manage multiple projects simultaneously. - Excellent written and verbal communication skills. - Proficiency in using relevant software and electronic systems for regulatory documentation management. - Ability to interpret the acceptability of data results. Mass General Brigham Incorporated 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.