Children's National Medical Center, ranked among the top 5 pediatric hospitals nationally, is recruiting an IRB Operations Manager to join the leadership team of its AAHRPP accredited human research protections program. Reporting to the Director of Research Regulatory Affairs, the IRB Operations Manager is accountable for achieving the human research protections program 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 will perform 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 about the appropriate level of review, interpretation and application of 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.
Program and Human Resource Management
- Ensure consistent, timely and high quality execution of IRB analyst workflows and deliverables.
- Continually assesses the current state of research and pursues a strategic plan that supports future growth as it pertains to human subject research protections including resource and FTE needs, programmatic needs, and necessary compliance initiatives.
- 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.
- 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.
- Assist in identifying and tracking key performance metrics for reporting staff performance management and integrates performance metrics into performance reviews.
- Conduct regular staff meetings and addresses issues such as conflict and individual performance issues.
- Reviews and analyzes overall performance metrics to ensure consistency among the IRB staff and the IRB Committee(s).
- Monitor the submission workflow in the electronic IRB system to ensure continued efficiency, including triaging tasks dependent upon volume and priority. Identify process improvement opportunities to increase efficiency and effectiveness, while maintaining high standards of compliance and collaboration.
- Promote best practices, measure and maintain performance and make adjustments to improve both efficiency and effectiveness.
- Model positive, direct communication and conflict resolution
- Provide oversight for the ongoing work of the IRBs in conducting human subject protections review, including administrative operations, providing orientation to new IRB members.
- Ensure appropriate documentation of IRB actions, and maintain records and correspondence related to IRB activity in accordance with applicable regulations, laws and accreditation standards.
- Utilize IRB metrics reporting tools to provide strategic insight into opportunities for quality and process improvement; prepares and submit regular narrative reports related to IRB and HRPP activities to Director of Research Regulatory Affairs.
- Manage member evaluation process, manage the appointment/reappointment process and evaluation process
- Understand the impact of any proposed regulatory changes on institutional policies pertaining to human subject research and implement policy and procedure changes as appropriate
- Oversee IRB reviewer assignments and attendance to ensure appropriate expertise is present/available.
- Ensure compliance with policies & procedures and inform IRB team members of changes in policy and procedure
- Conduct quality assurance review for IRB meeting minutes and general post-review correspondence and attend IRB meetings.
- Assist with training of new IRB members and serve as a contact for member questions/concerns.
- 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.
- Serve as a liaison between the research community, the IRB staff and IRB members and educates all stakeholders on relevant and emerging regulations and policies and any related risk management issues.
- Maintain and update regulatory compliance documentation including FWA, IRB Registration with OHRP, IRB Rosters, and other necessary documentation such FDA communications and communication, Reliance Agreements, Commercial IRB contracts\agreements, and memorandums of understanding as needed.
- Maintain knowledge of existing affiliation agreements, contracts, and memorandum of understandings that affect local context considerations and reporting requirements.
- Respond to researcher and IRB committee requests for clarification and guidance regarding ethical issues in biomedical and behavioral research involving human subjects.
Customer Support and Organizational Relationships
- Provide quality customer service and regulatory support to all constituents.
- Acts as a role model for other professionals by communicating responsively, respectfully, and positively.
- Reinforce clear expectations for customer service and consultancy.
- Solicit feedback from constituents.
- Provide guidance to staff in complex cases and assist in resolving complaints.
- Ensure the compliance and accuracy of the IRB intranet website, which include items such as: the IRBear application including IRB policies and procedures, reporting requirements, and SOPs.
- Collaborate with Director of Research Regulatory Affairs and Education and Accreditation Manager to maintain positive work environment and achieve the departmental objectives.
- 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, etc.)
- Participate in and support reporting of non-compliance and unanticipated problems to regulatory offices and communicates with federal regulatory offices as required.
Information Services, P&P and Reporting
- 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.
- Organize regular meetings of OPHS staff and leadership; develops meeting agenda and materials, take and distribute minutes.
- 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, etc.).
- Work to ensure that operational and support functions for the IRB Committees are provided and maintained.
- Support development of eIRB submission system manual revisions and development of FAQs, and other educational materials as required.
- Preparation of reports from IRB database and records as requested by leadership and stakeholders.
- Support development of eIRB system manual revisions and development of FAQs and educational materials as required.
- Support requirements development and tracking and project management for eIRB system enhancements and revisions as needed.
Management of research and education requirements with eIRB submissions system platform
Manages the institutional policy on human subject education and tracks certification for research personnel.
- Support policy development and program coordination for responsible conduct of research effort.t
- Represents the human research protections program in meetings related to RCR coordination.
- Reports on monitoring, training and education, RCR requirements and conflict of interest disclosure to the IRB and/or other institutional committees as required.
- Ensure compliance with national standards for the responsible conduct of research.
District of Columbia-Washington
Sheikh Zayed Campus 111 Michigan Avenue Washington 20010
Regular / Temporary:
FT - Full-Time
Sep 19, 2019, 2:42:24 PM