Regulatory Coordination/Quality Assurance Manager

The General Hospital Corporation; Somerville (MA); In loco; USD 85.000 - 110.000; Tempo pieno

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Organizational skills

Communication skills

Analytical skills

Problem solving

Staff supervision

Budget management

Formazione

Bachelor's Degree in related field

Master's Degree preferred

Strumenti

Veeva SiteVault

Descrizione del lavoro

Site: The General Hospital Corporation

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

Summary

The position reports directly to the Sr Project Manager and/or Project Director of a large global clinical study. This position has management responsibility for specific roles within a clinical study assigned to support the day-to-day operational project management of assigned trial(s).

Does this position require Patient Care?

No

Essential Functions

• Collaborating with project investigators and research sites to ensure targets are met for study start up, site activation, patient recruitment and enrollment.
• Safety management and reporting to FDA, Data and Safety Monitoring Boards, Medical Monitors, funding agencies and other regulatory bodies.
• Collecting, reviewing and approving of all required regulatory documents; and working to ensure the study Trial.
• Managing multi-center trials funded by NIH, Industry standards.
• Collaborate with grants management team to prepare progress reports.
• Provide safety management oversight for studies, in collaboration with study PI and safety boards.

Qualifications

Education

Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred

Can this role accept experience in lieu of a degree?

No

Experience

Progressively more responsible experience in a research related field 3-5 years required and Prior Supervisory Experience 1-2 years preferred

Knowledge, Skills and Abilities

• Strong organizational and communication skills.
• Demonstrated analytical skills.
• Effective problem solving skills.
• Ability to supervise and train staff effectively.
• Strong database management and computer skills.
• Must possess aptitude for budget management.

Additional Job Details (if applicable)

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 NCR