Senior Regulatory Affairs Coordinator

1200 The General Hospital Corporation; Somerville (MA); Hybrid; USD 51,000 - 82,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Job summary

Mass General Brigham is seeking an experienced Regulatory Affairs Coordinator for a nationwide Alzheimer's platform trial within the McCance Center. You will serve as the Center’s regulatory expert, leading regulatory risk management, planning, and regulatory operations for the clinical trial program.

Working closely with leadership, investigators, IRBs, and sponsors, you will provide regulatory guidance, ensure compliance, prepare essential documents, and mentor staff on regulatory requirements

Qualifications

• Regulatory requirements for clinical research, including FDA regulations.
• Experience with IRBs, regulatory submissions, and regulatory documentation.
• Strong organizational and project management skills.

Responsibilities

• Ensure all research activities, documents, and processes adhere to relevant regulations.
• Oversee the preparation, submission, and tracking of study-related documents to the IRB.
• Prepare and maintain essential regulatory documents (investigator brochures, consent forms, study protocols).
• Collaborate with research teams to initiate studies, including regulatory document collection and site activation.
• Support audits related to regulatory compliance and documentation.
• Oversee adverse event reporting and safety monitoring.

Skills

Regulatory affairs

FDA regulations

Clinical trial regulatory

Project management

Communication

Education

Bachelor's Degree Healthcare Management

Bachelor's Degree Related Field of Study

Master's Degree Related Field of Study

Job description

Site

The General Hospital Corporation 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.

Job 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. 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. Does this position require Patient Care? No

Essential Functions

• 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

EEO Statement: 1200

The General Hospital Corporation 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 (857)-282-7642.

Mass General Brigham Competency Framework

At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline. Combat disease. Hold a hand. Help people. Impact the world. Mass General Brigham is a passionate, welcoming community where minds meet caring hearts. Come be a part of the world’s most powerful force in medicine, where every role is important in changing lives. Are you ready? Our history includes New England hospitals founded over 200 years ago, some of the first and most prestigious hospitals in the world. Built on the legacy of two leading academic medical centers, we’re more than a system—we’re leaders in the practice of medicine. Mass General Brigham is committed to serving the community. We are dedicated to enhancing patient care, teaching and research, and taking a leadership role as an integrated health care system. We recognize that increasing value and continuously improving quality are essential to maintaining excellence.