Regulatory & Quality Assurance Manager – Clinical Research

The General Hospital Corporation; Somerville (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

The General Hospital Corporation is seeking a Regulatory Coordinator for the Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital. This role focuses on QA, regulatory affairs, SOP development, and staff training to ensure compliance with GCP, regulations, and policies.

Reporting to the NCRI Director, Quality Assurance, the position supports both ARO and investigational sites, including audits, training, and policy development within a large, academic research

Qualifications

• Bachelor's degree in a related field required or a master's degree preferred.
• 3–5 years progressive research-related experience required.
• 1–2 years supervisory experience preferred.
• Strong organizational and communication skills necessary.
• Demonstrated analytical and problem solving abilities.
• Ability to supervise and train staff effectively and manage budgets.

Responsibilities

• ARO-Level responsibilities include QA plan tasks and audit activities.
• Perform on-site and remote site audits and draft audit reports.
• Review NCRI staff adherence to policies and procedures.
• Draft and revise NCRI SOPs and policies; develop GCP training for staff.
• Support QA director during sponsor audits and regulatory inspections.
• At investigational sites, draft site procedures and guide staff during monitoring visits.

Skills

Organizational skills

Communication skills

Analytical skills

Problem solving

Staff supervision

Budget management

Education

Bachelor's Degree in related field

Master's Degree preferred

Tools

Veeva SiteVault

Job description

The General Hospital Corporation is seeking a Regulatory Coordinator for the Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital. This role focuses on QA, regulatory affairs, SOP development, and staff training to ensure compliance with GCP, regulations, and policies.

Reporting to the NCRI Director, Quality Assurance, the position supports both ARO and investigational sites, including audits, training, and policy development within a large, academic research