Children's National Medical Center, ranked among the top 10 pediatric hospitals nationally, is recruiting an IRB Operations Manager to join the leadership team of its AAHRPP-accredited human research protections program (HRPP). Reporting to the Director of Research Regulatory Affairs, the IRB Operations Manager is accountable for achieving the HRPP mission of protecting the rights, safety and welfare of children and families participating in research at CNMC. The IRB Operations Manager oversees day-to- day operations of the Office for the Protections of Human Subjects (OPHS), manages IRB staff, provides regulatory support to Board Members, and plans, develops and implements processes and materials to ensure high quality and timely human subjects protection reviews and enhance the quality of research submissions. The IRB Operations Manager performs highly complex duties to facilitate the review and approval process conducted by IRB staff and Committees. This will include providing regulatory support and guidance to multiple institutional stakeholders and utilizing metrics to monitor, troubleshoot, and improve efficiency of operations. The IRB Operations Manager will interpret and apply federal and state laws, regulations, institutional policies and guidelines to protect human subjects and to ensure institutional compliance. The IRB Operations Manager will collaborate with multiple institutional stakeholders to enhance HRPP initiatives.
Demonstrate clear, high-level knowledge, practice, and application of HHS regulations, FDA regulations and guidance, ICH/GCP guidelines, HIPPA Privacy Rule, and institutional HRPP and institutional policies related to human subject protection and clinical research to ensure compliance.
Provide leadership and regulatory guidance to IRB Staff, IRB Members, and the research community in all aspects of day-to-day IRB operations – maintaining a culture of excellence, and superior customer service.
Understand the impact of any proposed regulatory changes on institutional policies pertaining to human subject research and implement policy and procedure changes as appropriate.
Participate in and support reporting of non-compliance and unanticipated problems to regulatory offices and communicates with federal regulatory offices as required.
Maintain and update regulatory compliance documentation including IRB Registration with OHRP, IRB Rosters, and other necessary correspondence with federal regulatory offices.
Manage IRB member appointment, reappointment, and evaluation process.
Collaborate with Director of Research Regulatory Affairs and Education and Accreditation Manager to maintain positive work environment and achieve the departmental objectives.
Serve as the direct supervisor for IRB analysts and administrative staff, including tracking performance, conducting annual performance evaluations and providing guidance in operations or human research regulations as necessary.
Ensure consistent, timely and high quality execution of IRB analyst workflows and deliverables.
Provide guidance to staff in complex cases and assist in resolving complaints.
Monitor the submission workflow in the electronic IRB system to ensure continued efficiency, and triage tasks dependent upon volume and priority. Identify process improvement opportunities to increase efficiency and effectiveness, while maintaining high standards of compliance and collaboration.
Provide regular reports and required updates to the Director of Research Regulatory Affairs on IRB operations and identify and propose solutions for potential compliance challenges or high risk or sensitive issues.
Utilize IRB metrics reporting tools to provide strategic insight into opportunities for quality and process improvement; prepare and submit regular narrative reports related to IRB and HRPP activities to Director of Research Regulatory Affairs. Review and analyze overall performance metrics to ensure consistency among the IRB staff and the IRB Committee(s).
Model positive, responsive, and respectful verbal and written communications.
Serve as back-up to Education and Accreditation Lead on other delegated projects (e.g., AAHRPP annual report preparation, Human Subjects Protections Training for research community).
Support development of eIRB system manual revisions and development of FAQs and educational materials as required.
Bachelor's degree from an accredited college or university and 6 years IRB/HRPP experience, or Master's degree from an accredited college or university and 3 years IRB/HRPP experience
Working knowledge of federal regulations applying to IRBs, including 21 CFR 50 and 56, and 45 CFR 46
Experience in management and development of professional staff
Effective interpersonal/negotiation skills
Effective written and verbal communication skills
Proficient with IT tools including databases
Proficient in word processing and previous experience with MS office programs (MS word, Access, Excel) required
Additional Salary Information: Competitive salary commensurate with experience.
Internal Number: 1900017Y
About Children's National Health System
Research at Children’s National is conducted through Children’s Research Institute (CRI), the academic arm of Children’s National Health System. Our research includes all translational, clinical, and community studies. Children’s Research Institute also oversees the educational activities and academic affairs of Children's and the Department of Pediatrics at the George Washington University School of Medicine and Health Sciences. We frequently partner with many other research institutions regionally and nationally.
Children’s Research Institute conducts and promotes translational and clinical medical research and education programs within Children’s National that lead to improved understanding, prevention, treatment, and care of childhood diseases.