Clinical Research Regulatory Coordinator II

Site:
Mass General Brigham Incorporated

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 is also responsible for disseminating all updates on the clinical trial review process to the sponsor and the research study team.

• 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

• 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

Experience

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.

• Remote Type:
  Remote
• Work Location:
  
  101 Merrimac Street
• Scheduled Weekly
  
  Hours:
  
  40
• Employee Type:
  Regular
• Work Shift:
  
  Day (United States of America)
• Pay Range: $24.28 - $39.43/Hourly
• Grade: 6

0100 Mass General Brigham Incorporated is an Equal Opportunity Employer. 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.

To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at .