Clinical Research QA & Regulatory Lead (Hybrid)

Mass General Brigham; Somerville (MA); Hybrid; USD 63,000 - 103,000; Full time

Job summary

Mass General Brigham seeks a Regulatory Coordinator to manage QA and regulatory activities for NCRI, focusing on GCP compliance, audits, and site procedures. You will draft SOPs, conduct internal reviews, and coordinate with investigators and sites to ensure adherence to regulations.

The role requires 3+ years in clinical research or QA, a scientific degree, and strong leadership and communication skills. Hybrid onsite/remote work is available at MGH facilities.

Qualifications

• Bachelor’s degree in a scientific, healthcare, clinical research, regulatory, quality, or related discipline.
• Minimum 3 years of experience in clinical research, academic research, or quality assurance.
• Experience with regulatory inspections and audits preferred.
• Ability to lead and mentor cross‑functional teams.

Responsibilities

• Develop and revise site SOPs and guidance; support QA programs.
• Perform internal reviews and monitor regulatory compliance and GCP.
• Assist with sponsor audits and regulatory inspections; prepare audit reports.
• Provide training on GCP and QA processes to staff.

Skills

Time management

Leadership

Communication

Regulatory knowledge

Problem solving

GCP familiarity

Team collaboration

Education

Bachelor’s degree in a scientific/healthcare/clinical research field

Master’s degree preferred

Tools

Microsoft Office

Veeva SiteVault

Job description

Mass General Brigham seeks a Regulatory Coordinator to manage QA and regulatory activities for NCRI, focusing on GCP compliance, audits, and site procedures. You will draft SOPs, conduct internal reviews, and coordinate with investigators and sites to ensure adherence to regulations.

The role requires 3+ years in clinical research or QA, a scientific degree, and strong leadership and communication skills. Hybrid onsite/remote work is available at MGH facilities.