Regulatory Coordination/Quality Assurance Manager

Mass General Brigham•Somerville, MA

2d•$63,253 - $102,596•Hybrid

About The Position

The Regulatory Coordination/Quality Assurance Manager supports clinical research quality and regulatory compliance for the Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital. The role reports to the Senior Project Manager and/or Project Director for assigned clinical studies and, in its regulatory and quality assurance work, receives general direction from the NCRI Director of Quality Assurance and Regulatory Affairs. The position supports both the NCRI Academic Research Organization and investigational sites, implementing the NCRI Quality Management Plan and helping ensure research is conducted in accordance with applicable regulations, good clinical practice (GCP), and institutional policies and procedures. At the ARO level, the position implements quality initiatives, conducts audits and internal reviews, drafts and revises policies and standard operating procedures, reviews protocols and study plans, develops and delivers GCP training, and supports sponsor audits and regulatory inspections. It tracks quality observations and verifies the effectiveness of corrective actions, supports process improvement and inspection readiness, advises staff on compliance, and supervises QA Specialists or QA Managers. At the investigational-site level, the position develops site procedures and guidance, reviews adherence to procedures and protocols, prepares reports and observations to guide quality improvement, supports monitoring visits, sponsor audits, and regulatory inspections, and advises staff and investigators on regulatory compliance. It performs root cause analysis, develops and monitors corrective and preventive action plans, manages GCP training, assists Principal Investigators with regulatory submissions, and serves as business owner for Veeva SiteVault. The position may also support clinical-study operations, including study start-up, site activation, recruitment and enrollment, safety management and reporting, regulatory document review, and progress reports. The position is hybrid, with two days weekly onsite at MGH and the remaining three days onsite at Assembly Row or remote. Reliable internet access is required. Occasional onsite attendance for meetings, sponsor audits, or regulatory inspections may be required, with advance notice. Travel by public roads and air may be required, including occasional U.S. travel to audit investigational sites or vendors.

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 time-management and organizational skills.
Confident presentation skills, including presenting to large audiences.
Excellent leadership, written communication, and verbal communication skills.
Understanding of clinical research methodology and FDA, OHRP, and ICH guidelines and regulations, with the 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 develop and manage positive relationships with sponsor representatives, study-team members, and vendors.
Ability to lead and mentor cross-functional teams.
Ability to supervise and train staff effectively.
Strong analytical and problem-solving skills, database management and computer skills, and aptitude for budget management.
Reliable access to the internet.
Willingness and ability to travel by public roads and air as needed, including occasional travel within the United States to audit sites or vendors.

Nice To Haves

Master’s degree in a related field.
One to two years of prior supervisory experience.
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 quality initiatives and tasks in the NCRI Quality Management Plan.
Conduct onsite and remote site audits and prepare audit reports documenting observations.
Review NCRI staff adherence to written policies, procedures, and clinical trial protocols.
Draft and revise NCRI and investigational-site policies, SOPs, and guidance.
Review protocols and study plans for consistency with institutional policies, SOPs, regulations, and GCP.
Develop and deliver GCP training for ARO and site staff, including additional training based on issues identified in reviews.
Advise NCRI staff, site staff, study teams, and investigators on regulatory compliance and GCP.
Support process-improvement and inspection-readiness initiatives and communicate with NCRI leadership and sponsors.
Assist with sponsor audits and regulatory-authority inspections of clinical trials, including support for monitoring visits.
Track quality observations and corrective actions and assess the effectiveness of actions taken after audits, inspections, and internal reviews.
Perform root cause analyses and develop, implement, and assess corrective and preventive action plans (CAPAs).
Supervise QA Specialists or QA Managers.
Assist NCRI Principal Investigators with submissions to regulatory authorities.
Serve as business owner for Veeva SiteVault.
Support clinical-study operations, including study start-up, site activation, recruitment and enrollment, safety management and reporting, regulatory document review, and preparation of progress reports.
Accept responsibility for special projects as requested.