Senior Regulatory Affairs Coordinator

Regulatory Affairs Coordinator

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. 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. Experience with federal and local regulatory boards is considered an asset.

The McCance Center is an interdisciplinary research center dedicated to promoting healthy brain aging and preventing neurodegenerative disease through innovative research. The Center is in an exciting phase of growth, advancing a single-site trial of a novel natural product combination and a first-of-its-kind Alzheimer's disease platform trial designed to accelerate the evaluation of multiple promising therapies for early intervention.

Responsible for managing and overseeing the regulatory aspects of clinical research studies through ensuring compliance with applicable regulations, ethical guidelines, and institutional policies to facilitate the successful conduct of clinical trials and other research projects.

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.

Qualifications:

Education:

Bachelor's Degree Healthcare Management required or Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred.

Can this role accept experience in lieu of a degree? No

Licenses and Credentials:
Experience Clinical Research Regulatory Affairs Experience 3-5 years required.

Knowledge, Skills and Abilities:

• Strong understanding of regulatory requirements for clinical research, including Food and Drug Administration regulations.
• Familiarity with electronic data capture systems, electronic medical records, and clinical trial management systems.
• Knowledge of research compliance regulations and ethical considerations in clinical research.
• Excellent organizational and project management skills to manage multiple clinical trials and regulatory submissions simultaneously.
• Effective communication and interpersonal skills for collaboration with diverse stakeholders, regulatory authorities, and sponsors.
• Demonstrated problem-solving abilities and the capability to adapt to changing regulatory landscapes.

Additional Job Details (if applicable):

Remote Type:
Hybrid

Work Location:

399 Revolution Drive

Scheduled Weekly

Hours:

40

Employee Type:
Regular

Work Shift:

Day (United States of America)

Pay Range: $50,502.40 - $82,014.40/Annual

Grade: 6

At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications;

however, it does not encompass all elements contributing to your total…