Process Improvement and Education Manager, IRB

Boston Children's Hospital; Boston (MA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Flexible schedules

Health, vision and dental insurance

Child care subsidies

Student loan subsidies

Generous time off

403(b) Retirement Savings plan

Pension

Tuition reimbursement

License and Certification Reimb.

Cell phone plan discounts

T-pass discounts

Job summary

Boston Children's Hospital seeks a Process Improvement and Education Manager for the IRB to lead education, process improvement and compliance initiatives. You will drive efficiency, policy development, audits, and stakeholder engagement across the clinical research community, ensuring adherence to federal/state regulations and BCH policies protecting human subjects.

Responsibilities include developing best practices, collaborating with clinical research operations, and supporting accreditation

Qualifications

• 6+ years in clinical research regulatory environment
• IRB experience preferred
• Knowledge of HHS and FDA regulations
• Strong project management and communication skills

Responsibilities

• Under the Senior Director of Clinical Research Compliance, manages Process Improvement, regulatory policy, auditing, and Education efforts to ensure compliance with federal/state regulations and BCH policies protecting human subjects in clinical research.
• Serves as liaison between IRB staff, members, and the clinical research community to identify inefficiencies and propose improvements to review processes, communications, forms, and education.
• Develops and maintains policies, guidance, reviewer worksheets, and resources to support regulatory compliance and efficient IRB review and oversight.
• Works with the Director of Clinical Research Compliance to support implementation, use, and maintenance of the electronic IRB protocol management system.
• Oversees and participates in audits evaluating IRB and investigator adherence to regulations and institutional policies governing human subject research.
• Collaborates with Clinical Research Operations on audits, QI initiatives, and human subject protection policies and procedures.
• Analyzes audit data and prepares reports with findings and recommendations to improve human subject and IRB compliance and efficiency.
• Directs and participates in educational programs for IRB members, staff, and the research community on human subject protection regulations and IRB policies.

Skills

Project management

Regulatory compliance

Audit & QA

Stakeholder engagement

Data analysis

Education

Master's degree in Life sciences, nursing, pharmacy or related field

Tools

eIRB system

Job description

Position Summary

The Process Improvement and Education Manager will be responsible for managing and overseeing the IRB's education and process improvement initiatives to ensure compliance with federal and state regulations and BCH's policies governing the protection of human subjects in clinical research. They will lead efforts to enhance IRB processes, quality, efficiency, and stakeholder experience through strategic planning, development of best practices, collaboration across the clinical research community, and ongoing evaluation of compliance and operational effectiveness. They will also represent the IRB as needed in external initiatives and accreditation activities.

Key Responsibilities

• Under the Senior Director of Clinical Research Compliance, manages Process Improvement, regulatory policy, auditing, and Education efforts to ensure compliance with federal/state regulations and BCH policies protecting human subjects in clinical research.
• Serves as liaison between IRB staff, members, and the clinical research community to identify inefficiencies and propose improvements to review processes, communications, forms, and education.
• Develops and maintains policies, guidance, reviewer worksheets, and resources to support regulatory compliance and efficient IRB review and oversight.
• Works with the Director of Clinical Research Compliance to support implementation, use, and maintenance of the electronic IRB protocol management system.
• Oversees and participates in audits evaluating IRB and investigator adherence to regulations and institutional policies governing human subject research.
• Oversees and participates in for-cause audits of protocols and/or investigators, as requested by the IRB, Department Chair/Chief, or Institutional Official, to address human research protection concerns or non-compliance.
• Collaborates with Clinical Research Operations on audits, QI initiatives, and human subject protection policies and procedures.
• Analyzes audit data and prepares reports with findings and recommendations to improve human subject and IRB compliance and efficiency.
• Directs and participates in educational programs for IRB members, staff, and the research community on human subject protection regulations and IRB policies, including webinars, newsletters, and website content.
• Develops benchmarks and best practices for compliance with human subject protection regulations and policies; supports accreditation applications, site visits, responses, and corrective actions.
• Uses project management tools to develop work plans, manage scope and risks, coordinate communications, and prioritize tasks based on importance and urgency.
• Contributes to short- and long-term strategic plans addressing regulatory changes and enhancing IRB effectiveness and operational efficiency.

Minimum Qualifications Education:

• Master's in Life sciences, nursing, pharmacy or a closely related field.

Experience:

• Minimum of 6 years' experience in clinical research regulatory environment. IRB experience preferred.
• Knowledge of HHS and FDA regulations, clinical research monitoring, data management and analysis, auditing principles and techniques, and experience developing and implementing process improvement initiatives, including benchmarks and metrics. Ability to conduct interviews, analyze information, and prepare clear, concise audit reports.
• Strong project management, organizational, analytical, written, and verbal communication skills, with the ability to collaborate effectively with diverse groups, including hospital faculty, staff, and study sponsors.

The posted pay range is Boston Children's reasonable and good-faith expectation for this pay at the time of posting.

Any base pay offer provided depends on skills, experience, education, certifications, and a variety of other job-related factors. Base pay is one part of a comprehensive benefits package that includes flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.