IRB Process Improvement & Education Manager

Boston Children's Hospital

Boston (MA)

On-site

USD 120,000 - 160,000

Full time

7 days ago

Be an early applicant

Application generator

Turn this role into an interview — a resume and cover letter built around what this employer wants.

Get past ATS filters

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.