Regulatory Coordination/Quality Assurance Manager

Mass General Brigham•Somerville, MA

1d•Hybrid

About The Position

The Regulatory Coordinator supports the Neurological Clinical Research Institute (NCRI) Academic Research Organization and investigational sites by implementing quality initiatives in accordance with the NCRI Quality Management Plan, applicable regulations, Good Clinical Practice (GCP) guidelines, and institutional policies and procedures. The role receives general direction from the NCRI Director of Quality Assurance and Regulatory Affairs and supports research quality, regulatory compliance, staff training, and inspection readiness. It is divided approximately equally between ARO-level and investigational site-level responsibilities and includes business ownership of Veeva SiteVault. At the ARO level, the role implements quality management activities, conducts audits and internal reviews, drafts and revises policies and standard operating procedures, reviews study protocols and plans, and develops and delivers GCP training. It advises staff on regulatory compliance, supports sponsor audits and regulatory inspections, and tracks corrective actions through resolution and effectiveness checks. The position also supervises QA Specialists or QA Managers and contributes to quality and process improvement initiatives. At the investigational site level, the role develops and updates site procedures, reviews staff adherence to procedures and protocols, prepares review reports, and supports sponsor audits and regulatory inspections. It performs root cause analysis and develops corrective and preventive action plans, provides GCP training, assists Principal Investigators with regulatory submissions, and advises site staff on compliance and GCP. The role may travel within the United States to audit sites or vendors and requires two days per week onsite at MGH; the remaining three days may be onsite at Assembly Row or remote. Occasional additional onsite attendance may be required for meetings, audits, or inspections.

Requirements

Bachelor's degree in a scientific, healthcare, clinical research, regulatory, quality, or related discipline; experience cannot substitute for the degree.
At least three years of work experience related to clinical research, academic research, quality assurance, or a similar environment.
High level of time-management and organizational skills.
Confident presenting to large audiences.
Excellent leadership and written and verbal communication skills.
Solid understanding of clinical research methodology and regulations, including FDA, OHRP, and ICH guidance and regulations, and ability to advise study teams on implementation.
Ability to identify problems and develop potential solutions.
Excellent computer skills, including Microsoft Office.
Ability to work independently and collaboratively in a fast-moving, deadline-driven environment while balancing multiple tasks.
Ability to make independent, effective decisions.
Ability to build and manage positive relationships with sponsor representatives, study team members, and vendors.
Ability to lead and mentor cross-functional teams.
Reliable access to the internet.
Ability to travel by public roads and air as needed.

Nice To Haves

Master's degree in a related field.
Two or more years of experience as a clinical research coordinator at an investigational site.
Background or familiarity with biology or another scientific discipline.
Professional certification in clinical research, quality assurance, regulatory affairs, or a related field.

Responsibilities

Implement tasks in the NCRI Quality Management Plan, including quality functions, tracking processes, action plans, and goals.
Conduct on-site and remote audits of research sites and draft audit reports documenting observations.
Review NCRI staff adherence to written policies and procedures.
Draft and revise NCRI policies and standard operating procedures.
Develop and conduct Good Clinical Practice training for ARO staff and investigational site staff.
Review protocols and study plans for consistency with institutional policies, procedures, regulations, and GCP.
Advise NCRI and site staff on regulatory compliance and GCP.
Support process improvement and inspection-readiness initiatives following internal reviews, audits, and inspections.
Assist with sponsor audits and regulatory authority inspections of clinical trials.
Track quality observations and corrective actions, and monitor the effectiveness of actions taken.
Supervise QA Specialists or QA Managers.
Conduct internal reviews of site staff adherence to procedures and clinical trial protocols, and prepare summary reports with observations.
Perform root cause analysis, develop corrective and preventive action plans (CAPAs), and conduct effectiveness checks.
Assist NCRI Principal Investigators with drafting submissions to regulatory authorities.
Serve as business owner for Veeva SiteVault.
Accept responsibility for special projects as requested.
Travel as needed, including occasional U.S. travel to audit investigational sites or vendors.