IRB Process Improvement & Education Leader

Boston Children’s Hospital; Boston, Northern (MA, KY); Hybrid; USD 105,000 - 145,000; Full time

Job summary

Boston Children's Hospital’s IRB seeks a Process Improvement and Education Manager to drive education and process improvement initiatives, ensuring compliance with federal and state regulations and BCH policies protecting human subjects in clinical research.

You will lead audits, policy development, and the implementation of the electronic IRB protocol management system, collaborating across the clinical research community to enhance quality, efficiency, and stakeholder experience.

Qualifications

• Master's degree in Life sciences, nursing, pharmacy or related field is required.
• Minimum of 6 years’ experience in clinical research regulatory environment.
• Knowledge of HHS and FDA regulations, clinical research monitoring, data management and analysis, auditing principles.

Responsibilities

• Oversee education and process improvement initiatives ensuring compliance with federal/state regulations and BCH policies.
• Serve as liaison between IRB staff, members, and the clinical research community to identify inefficiencies and propose improvements.
• Develop and maintain policies, guidance, reviewer worksheets, and resources for regulatory compliance and efficient IRB review.
• Support implementation and maintenance of the electronic IRB protocol management system.
• Lead audits evaluating IRB and investigator adherence to regulations and policies.
• Collaborate with Clinical Research Operations on audits, QI initiatives, and human subject protection policies.
• Analyze audit data and prepare reports with findings and recommendations.
• Direct and participate in educational programs for IRB members, staff, and researchers.

Skills

Regulatory compliance

Process improvement

Project management

Education program development

Stakeholder engagement

Education

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

Job description

Boston Children's Hospital’s IRB seeks a Process Improvement and Education Manager to drive education and process improvement initiatives, ensuring compliance with federal and state regulations and BCH policies protecting human subjects in clinical research.

You will lead audits, policy development, and the implementation of the electronic IRB protocol management system, collaborating across the clinical research community to enhance quality, efficiency, and stakeholder experience.