Clinical Research Regulatory Coordinator II
About The Position
Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. The Regulatory Affairs Coordinator II (RAC II) is responsible for the collection, completion and submission of regulatory documents to the clinical trial sponsors and the Institutional Review Board (IRB). The RAC II works independently to monitor, track and facilitate regulatory reports to and from all the IRB committees and if necessary, the clinical trial sponsor. The RAC II is also responsible for the maintenance of all clinical trial regulatory documents and files during the IRB review process. The position of RAC is also responsible for disseminating all updates on the clinical trial review process to the sponsor and the research study team.
Requirements
- 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
- Bachelor's Degree Healthcare Management required or Bachelor's Degree Related Field of Study required
- Regulatory Affairs Experience 2-3 years required
- 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.
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Hospitals
Number of Employees
5,001-10,000 employees
