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:
Education:
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.
Education:
- Master's in Life sciences, nursing, pharmacy or a closely related field.
- 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.
Numbers & Facts
| Location | Boston, MA |
Skills
- Analysis Skillsunmatched
- Auditingunmatched
- Benchmarkingunmatched
- Best Practicesunmatched
- Biologyunmatched
- Clinical Monitoringunmatched
- Clinical Practices/Protocolsunmatched
- Clinical Researchunmatched
- Communication Skillsunmatched
- Corrective Actionunmatched
- Data Analysisunmatched
- Data Managementunmatched
- Department of Health and Human Servicesunmatched
- Develop Methodologiesunmatched
- Establish Prioritiesunmatched
- FDA Requirementsunmatched
- Federal Laws and Regulationsunmatched
- Hospitalunmatched
- IRB/IEC (Institutional Review Board/Independent Ethics Committee)unmatched
- Interviewing Skillsunmatched
- Maintain Complianceunmatched
- Metricsunmatched
- Newsletterunmatched
- Nursingunmatched
- Operational Auditunmatched
- Operations Processesunmatched
- Operations Researchunmatched
- Pharmacyunmatched
- Policy Developmentunmatched
- Presentation/Verbal Skillsunmatched
- Process Improvementunmatched
- Process Managementunmatched
- Project Management Softwareunmatched
- Project Planningunmatched
- Project/Program Managementunmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Reporting Skillsunmatched
- Risk Managementunmatched
- Software Administrationunmatched
- State Laws and Regulationsunmatched
- Strategic Planningunmatched
- Team Playerunmatched
- Webinarunmatched
- Writing Skillsunmatched
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