Hybrid Regulatory & QA Lead, Clinical Research

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

Job summary

Mass General Brigham's Neurological Clinical Research Institute seeks a Regulatory Coordinator to manage QA activities, SOP development, and regulatory compliance across NCRI and investigative sites. You will draft procedures, train staff on GCP, and support audits and inspections.

The role involves hybrid work with 2 onsite days weekly at Mass General Hospital and occasional travel for regulatory activities, ensuring adherence to QMP, FDA, and ICH guidelines.

Qualifications

• Minimum bachelor's degree in a scientific/healthcare/clinical research/regulatory field.
• Master's degree preferred but not required.
• 3+ years of experience in clinical research or quality assurance.

Responsibilities

• Implement NCRI QAPlan tasks and track actions.
• Conduct internal reviews and audit reports.
• Develop, revise SOPs/policies and provide GCP training.
• Assist with sponsor audits and regulatory inspections.
• Support site staff with regulatory submissions and CAPAs.

Skills

Organizational skills

Communication skills

Analytical skills

Problem solving

Supervisory experience

Database management

Budget management

Microsoft Office

Education

Bachelor's degree in a scientific, healthcare, clinical research, regulatory, quality, or related discipline

Master's degree related field (preferred)

Tools

Veeva SiteVault

Microsoft Office

Job description

Mass General Brigham's Neurological Clinical Research Institute seeks a Regulatory Coordinator to manage QA activities, SOP development, and regulatory compliance across NCRI and investigative sites. You will draft procedures, train staff on GCP, and support audits and inspections.

The role involves hybrid work with 2 onsite days weekly at Mass General Hospital and occasional travel for regulatory activities, ensuring adherence to QMP, FDA, and ICH guidelines.