Senior Regulatory Affairs Coordinator
Mass General Brigham
Summary
The McCance Center for Brain Health, part of the Mass General Brigham (MGB) Department of Neurology and MGB Neuroscience Institute, is seeking an experienced Regulatory Affairs Coordinator for an innovative, nationwide Alzheimer's disease platform trial.
Job description
The incumbent will serve as the Center's primary regulatory expert, leading regulatory risk management and regulatory planning for the Center's clinical trial program. This position offers an exceptional opportunity to contribute to high-impact research with the potential to advance the prevention and treatment of Alzheimer's disease.
Working closely with McCance Center leadership, faculty investigators, study teams, Institutional Review Boards (IRBs), regulatory agencies, participating research sites, MGB teams, and collaborating institutions, the successful candidate will provide regulatory guidance, coordination, and leadership; navigate complex regulatory processes; develop regulatory operations and procedures; and train and mentor staff on requirements and best practices.
Essential Functions
- Monitor and interpret current regulatory requirements, guidelines, and standards applicable to clinical research studies.
- Ensure that all research activities, documents, and processes adhere to relevant regulations.
- Oversee the preparation, submission, and tracking of study-related documents to the IRB for ethics review and approval.
- Prepare and maintain essential regulatory documents, including investigator brochures, informed consent forms, and study protocols.
- Collaborate with research teams to ensure timely initiation of clinical studies, including regulatory document collection and site activation processes.
- Support internal and external audits related to regulatory compliance and documentation.
- Oversee adverse event reporting and safety monitoring in accordance with regulatory guidelines and study protocols.
Requirements
- Bachelor's Degree in Healthcare Management or related field required
- Master's Degree in related field preferred
- 3-5 years of Clinical Research Regulatory Affairs experience required
- Strong understanding of FDA regulations for clinical research
- Familiarity with electronic data capture systems, electronic medical records, and clinical trial management systems
- Knowledge of research compliance regulations and ethical considerations
- Excellent organizational and project management skills
- Effective communication and interpersonal skills
- Demonstrated problem-solving abilities and adaptability
Benefits
- Comprehensive benefits
- Career advancement opportunities
- Recognition programs
- Differentials, premiums and bonuses
Company overview
Mass General Brigham is one of the largest integrated healthcare delivery systems in the United States, formed through the merger of Massachusetts General Hospital and Brigham and Women's Hospital. Based in Boston, Massachusetts, this academic medical center system operates multiple hospitals, specialty facilities, and community health centers throughout New England. The organization is renowned for its world-class patient care, cutting-edge medical research, and comprehensive medical education programs. As a teaching affiliate of Harvard Medical School, Mass General Brigham trains the next generation of healthcare professionals while advancing medical science through groundbreaking research initiatives. The system provides a full continuum of healthcare services, from primary care and preventive medicine to complex specialty treatments and emergency services. With a focus on innovation and patient-centered care, Mass General Brigham consistently ranks among the top hospital systems in the nation for clinical excellence and research output.