Senior Regulatory Affairs Coordinator

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

Job summary

Massachusetts General Hospital, part of Mass General Brigham, seeks an experienced Regulatory Affairs Coordinator to lead regulatory risk management for a nationwide Alzheimer's platform trial. You will collaborate with IRBs, regulatory agencies, investigators, and study teams to ensure compliance and timely trial initiation.

The role involves preparing submissions, maintaining essential regulatory documents, mentoring staff on requirements, and navigating FDA and local regulations across sites.

Qualifications

• Experience in regulatory affairs for clinical research.
• Knowledge of FDA regulations and ICH guidelines.
• Familiarity with IRB submission processes.
• Ability to train staff on regulatory requirements.

Responsibilities

• Monitor regulatory requirements for clinical studies.
• Prepare and submit regulatory documents to IRBs.
• Maintain essential regulatory documents and trial master files.
• Coordinate with investigators, sponsors, and regulatory authorities.
• Support audits and adverse event oversight.
• Oversee site activations and regulatory compliance across sites.
• Provide regulatory guidance to study teams.

Skills

Regulatory affairs

Clinical research

FDA regulations

IRB coordination

Education

Bachelor's degree in Healthcare Management

Bachelor's degree in related field

Master's degree in related field (preferred)

Tools

EDC systems

EMR systems

CTMS

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.

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.

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 compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth.

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.