Regulatory Coordination/Quality Assurance Manager II

Brigham and Women's Hospital • Somerville, MA

77d • $62,004 - $90,750 • Hybrid

About The Position

The Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital (MGH) is a premier Academic Research Organization (ARO) that manages clinical trials in neurological disorders. The NCRI employs physician clinical researchers, research nurses, project managers, data managers, SAS programmers, systems analysts, grants managers, research nurses, quality specialists, and administrative assistants dedicated to planning and implementing clinical trials. The Regulatory Coordinator will focus on regulatory and quality assurance aspects of clinical research. Receiving general direction from the NCRI Director Quality Assurance (QA) and Regulatory Affairs, the Regulatory Coordinator is responsible for implementing quality initiatives as outlined in the NCRI Quality Management Plan (QMP) and ensuring NCRI staff are conducting research projects according to the QMP, regulations, good clinical practice guidelines and institutional policies and procedures.

Requirements

• Bachelor's Degree.
• Minimum of five (5) years of working experience related to clinical research, academic research, quality assurance, or similar environment required.

Nice To Haves

• 2+ years as a clinical research coordinator at an investigational site.
• Background/familiarity with biology or other scientific disciplines is preferred, but not required.

Responsibilities

• Implement specific tasks outlined in the NCRI Quality Management Plan.
• Perform on-site and remote site audits and draft audit reports with observations.
• Oversee internal reviews of NCRI staff adherence to written policies and procedures.
• Develop new or revise current written procedures for NCRI, such as policies and SOPs.
• Develop and conduct training sessions on GCP for ARO staff.
• Review project-related protocols and study plans to ensure consistency and adherence to institutional policies and SOPs, regulations, and GCP.
• Act as a resource to NCRI staff and provide guidance/advice on regulatory compliance and GCP.
• Drive efforts on process improvement initiatives for inspection readiness following internal reviews, external audits/inspections.
• Assist with external sponsor audits of clinical trials.
• Assist with inspections of clinical trials by regulatory authorities.
• Compose, track, and monitor actions taken to address quality observations from external inspections/audits.
• Supervise the work performed by QA Specialists or QA Managers.
• Accept responsibility for special projects as requested.
• Develop new or revise current site-specific written procedures (SOPs and guidance).
• Perform internal reviews of staff adherence to written policies and procedures, and clinical trial protocols.
• Draft summary reports and associated observations from internal reviews to guide quality improvement initiatives and staff training.
• Assist with site inspections of clinical trials by regulatory authorities.
• Assist with external audits of clinical trials by industry sponsors.
• Monitor and ensure the effectiveness of actions taken to address observations from internal reviews and external inspections/audits.
• Provide oversight of corrective action and preventive action plans (CAPAs) and perform effectiveness checks.
• Develop, implement, and conduct a GCP training program for site staff.
• Drive efforts on process improvement initiatives for inspection readiness following internal reviews, external audits/inspections.
• Assist NCRI Principal Investigators with drafting submissions to regulatory authorities.
• Act as a resource for site staff by providing guidance/advice on regulatory compliance and GCP.

Benefits

• Comprehensive benefits package.
• Career advancement opportunities.
• Recognition programs designed to celebrate contributions and support professional growth.

What This Job Offers

• Job Type: Full-time
• Industry: Hospitals
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees