Reporting to the Children’s National Research Institute’s (CNRI), Vice President of Research Administration, the Director of Regulatory Affairs assumes responsibility – in close collaboration with the Regulatory Affairs Committee Chairs - will oversee the Office for the Protection of Human Subjects (OPHS)/Institutional Review Board (IRB) (85% effort), the Institutional Animal Care and Use Committee (IACUC) (10% effort), and the Institutional Biosafety Committee (IBC) (5% effort). The Director has an integral regulatory leadership role to facilitate research integrity in all stages of research (pre-study stage, active-study stage, post-study stage) and ensure compliance with applicable federal and local laws and regulations, as well as adherence to professional and ethical standards, institutional policies and procedures and observance of good practice quality guidelines (GxP), as they apply to research. These include but are not limited to GCP (Good Clinical Practice), GLP (Good Laboratory Practice), GSP (Good Safety Practice), and GMP (Good Manufacturing Practice). The Director is responsible for the oversight, administration, and coordination of all fiscal, human resources, administrative, and training activities of the regulatory committees (IRB, IACUC, IBC) with the goal to (1) improve the safe and efficient conduct of research, (2) to reduce administrative burden by improving operational efficiency, and (3) to accelerate protocol review and decision turnaround by improving review practices. The Director will develop policies and procedures (P&Ps) and ensure appropriate stakeholders are trained in the P&Ps and following them. This position will include responsibility for protocol review and approval and regular interaction with investigators and their research teams. The Director will manage the functional maintenance of the electronic IRB system that was built on the Click Commerce platform. She/he also will manage the operational aspects of maintaining and improving the functionality of the electronic system for the IACUC and the Research Animal Facility. The Director will serve on institutional research regulatory and compliance committees. The Director will participate in FDA, USDA, and other regulatory site inspections and coordinate internal audits with the research compliance program staff. The Director will manage the AAHRPP and AAALAC accreditation renewals as well as maintain the accreditation status in good standing.
Minimum Work Experience 5 years Management experience with budget responsibility. 8 years Human subjects research leadership experience
Progressive relevant experience in a federally funded research organization, overseeing regulatory committee operations
Experience working in an academic medical center IRB office strongly desired.
Advanced level of understanding of operational requirements related to the management and an IRB, IACUC and IBC, in an academic research setting
Experience with accreditation processes
Experience with managing electronic regulatory committee review systems
Certified IRB Professional (CIP) or Certified IRB Manager (CIM)
Certified Professional IACUC Administrator (CPIA)
Proven competency and knowledge of the Code of Federal Regulations (CFRs) with respect to human subjects and research animals
Knowledge of best practices in Federal Wide Assurance and Human Subjects Research
Advanced technical competence in wide range of research compliance issues
Advanced legal knowledge in risk management as applied to clinical research
Superior ability to manage relationships with researchers, staff and regulatory agencies.
Experienced and proficient in balancing regulatory compliance requirements against practical needs and limitations
Highly experienced program development and problem solving techniques
Ability to network and interact, as well as support effective partnerships with key groups and individuals.
Ability to prioritize ongoing and new projects, as well as conduct internal research and gather information
Ability to consult with clients and apply change management skills to influence formal and informal networks within the organization.
Ability to network and build effective, responsive relationships between researchers, academic/administrative departments and regulatory staff
Ability to lead change
Demonstrated leadership and management skills.
Excellent interpersonal as well as written and verbal communication skills
Experience in budget development and managing fiscal and operational aspects of a large department.
Telecommuting is allowed.
Internal Number: 200001DU
About Children's National Hospital
Research at Children’s National is conducted through the Children’s National Research Institute (CNRI), the academic arm of Children’s National Hospital. Our research includes all translational, clinical and community studies. Children’s National 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.
AAHRPP LogoChildren’s National 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. Children’s National is AAHRPP accredited.