Regulatory Coordination/Quality Assurance Manager

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

Job Summary

The Neurological Clinical Research Institute (NCRI), at Massachusetts General Hospital (MGH), is a premier Academic Research Organization (ARO) managing clinical research in neurological disorders. The NCRI employs multidisciplinary professionals dedicated to planning, implementation, oversight, and quality of clinical research.

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.

The Regulatory Coordinator role will support both the NCRI ARO and investigational site. At the ARO-level, the Regulatory Coordinator will draft, and revise policies and standard operating procedures (SOPs), perform internal reviews of staff adherence to written procedures, participate in computer system validation activities, and develop and conduct training sessions on aspects of Good Clinical Practice (GCP) for NCRI ARO Staff. The Regulatory Coordinator will support the Director of QA during external sponsor audits and inspections performed by regulatory agencies.

At the investigational site level, the Regulatory Coordinator role will draft and revise site-specific written procedures and guidance. The Regulatory Coordinator role will support research staff by performing internal reviews of research projects to identify trends that impact quality and facilitate monitoring visits, develop and implement a structured training program in GCP, and assist staff during monitoring visits, sponsor audits, and regulatory inspections. The Regulatory Coordinator is the business owner for Veeva SiteVault.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Relevant activities include, but are not limited to the following:

ARO-Level Responsibilities (50%):

• Implement specific tasks outlined in the NCRI Quality Management Plan, which defines QA functions, objectives, tracking processes, action plans, and identifies goals.
• Perform on-site and remote site audits and draft audit reports with observations.
• Perform internal reviews of NCRI staff adherence to written policies and procedures.
• Draft and 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, as needed.
• Support efforts on process improvement initiatives for inspection readiness following internal reviews, external audits/inspections, and have effective communication with NCRI ARO leadership and Sponsors.
• Assist with external sponsor audits of clinical trials.
• Assist with inspections of clinical trials by regulatory authorities.
• Compose, track, monitor, and ensure the effectiveness of 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.

Investigational Site-Level Activities (50%):

• 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.
• Perform root cause analysis, implement corrective action and preventive action plans (CAPAs), and perform effectiveness checks.
• Develop, implement, and conduct a GCP training program for site staff and additional training sessions based on trending issues identified during internal reviews.
• Drive efforts on process improvement initiatives for inspection readiness following internal reviews, external audits/inspections, and maintain effective communication with the NCRI Director of QA.
• 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, as needed.
• Accept responsibility for special projects as requested.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

• High level of time management and organizational skills.
• Confident presenting to large audiences.
• Excellent leadership, written and verbal communication skills.
• A solid understanding of clinical research methodology and regulations, including FDA, OHRP, and ICH guidelines and regulations related to the conduct of clinical research trials; and ability to advise study teams on how best to implement these regulations.
• Ability to identify problems and develop potential solutions.
• Excellent computer skills working with Microsoft Office.
• Team player who can work independently in an extremely fast-moving, deadline-driven environment, while balancing multiple tasks simultaneously.
• Ability to make independent, effective decisions.
• The ability to develop and manage positive relationships with sponsor representatives, study team members, and vendors.
• Ability to lead and mentor cross-functional teams.

LICENSES, CERTIFICATIONS, AND/OR REGISTRATIONS:

Professional certification in clinical research, quality assurance, regulatory affairs, or a related field is preferred but not required.

EDUCATION:

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

EXPERIENCE:
Required:

• Minimum of three (3) years of working experience related to clinical research, academic research, quality assurance or similar environment required.

Preferred:

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

WORKING CONDITIONS:

This position requires 2 days weekly onsite at MGH. The remaining 3 days can be onsite at the Assembly Row location or remote. Must have reliable access to internet. Occasionally, and at the discretion of the Director of QA, the Regulatory Coordinator may be required to be onsite for meetings, sponsor audits, or regulatory inspections. Advanced notice will be given.

Will travel by public roads and air travel as needed. On occasion, the Regulatory Coordinator may be required to travel within the United States to audit investigational sites or vendors at the discretion of the Director of QA.

Pay Range

Grade