Regulatory Lead, Clinical Trials (Alzheimer's Platform) - Hybrid

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

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.