New

Regulatory Coordination/Quality Assurance Manager II

Massachusetts General Hospital
United States, Massachusetts, Somerville
399 Revolution Drive (Show on map)
Oct 08, 2025
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. The Regulatory Coordinator role will support both the NCRI ARO and the investigational site. At the ARO-level, the Regulatory Coordinator will draft and revise polices 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, developing and implementing a structured training program in GCP, and assisting staff during monitoring visits, sponsor audits, and regulatory inspections. 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. Oversee internal reviews of NCRI staff adherence to written policies and procedures. Develop new or revise current written procedures for NCRI, such as polices 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. Drive 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, and 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. 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 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 have effective communication withthe 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 & 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 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. EDUCATION: Bachelor's Degree EXPERIENCE: Required: Minimum of five (5) 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 disciplines 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 on-site for meetings, sponsor audits, or regulatory inspections. Advanced notice will be given. Will travel on 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. The information contained in this document is intended to describe the general contents and requirements of work being performed by people assigned to this classification. It is not intended to be construed as an exhaustive statement of all duties, responsibilities or skills of individuals so classified. The General Hospital Corporation is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.