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 part of our Regulatory Support Request Team (RESORT). They will be responsible for the collection, completion and submission of regulatory documents to 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. 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.

Responsibilities

• Monitoring RESORT inbox throughout the day
• Provide support to study teams via e-mail and zoom
• Facilitate initial new trial submission for SRC and IRB review
• Maintain a working knowledge of the IRB’s current guidelines
• Prepare and submit protocol amendments
• Prepare and submit continuing reviews

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 required
• Regulatory Affairs Experience 2-3 years required
• 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.