Regulatory Coordination/Quality Assurance Manager

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 Licenses and Credentials 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 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.

Remote Type

Hybrid

Work Location

399 Revolution Drive

Scheduled Weekly Hours

40

Employee Type

Regular

Work Shift

Day (United States of America)

Pay Range

$63,252.80 - $102,596.00/Annual

Grade

7

At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

EEO Statement:

1200 The General Hospital Corporation is an Equal Opportunity Employer. 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. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.

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At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.