Children’s National Health System, based in Washington, DC, has been serving the nation’s children since 1870. Children’s National is Magnet® designated, and was ranked among the top 10 pediatric hospitals by U.S. News & World Report 2017-18. Home to the Children’s Research Institute and the Sheikh Zayed Institute for Pediatric Surgical Innovation, Children’s National is one of the nation’s top NIH-funded pediatric institutions. With a community-based pediatric network, seven regional outpatient centers, an ambulatory surgery center, two emergency rooms, an acute care hospital, and collaborations throughout the region, Children’s National is recognized for its expertise and innovation in pediatric care and as an advocate for all children.
As the nation’s children’s hospital, the mission of Children’s National Medical Center is to excel in Care, Advocacy, Research and Education. We accomplish this through:
•Providing a quality health care experience for our patients and families. •Improving health outcomes for children regionally, nationally, and internationally. •Leading the creation of innovative solutions to pediatric health challenges.
The Regulatory Specialist III: IRB Analyst is responsible for providing professional support to the Children’s National Medical Center Office for the Protection of Human Subjects and the Institutional Review Board (IRB). The IRB Analyst conducts protocol pre-reviews of full-Board and expedited studies; applies knowledge of human subjects protections regulations and institutional policies to support and manage IRB Committee meetings and required documentation and communicates IRB decisions to investigators. The analyst provides consultation and education to investigators and research staff.
Specific Requirements and Preferences
Three or more years’ experience working in an IRB/Research Compliance office with increasing responsibilities are required. If applicants are not currently CIP (Certified IRB Professional) certified, certification will be required within a year of starting this position.
Applicants must have extensive knowledge of federal human subjects research regulations and guidance documents, scientific/medical terminology as well as the ability to analyze and apply this knowledge to the review of biomedical, social and behavioral sciences research protocols involving vulnerable populations. This position requires strong analytic skills and the ability to manage multiple, complex activities while maintaining close attention to detail. Applicants must have strong organizational abilities and demonstrated success in meeting multiple deadlines. Applicants must demonstrate sound professional judgment, excellent problem-solving, organizational, interpersonal, and time management skills and the ability to communicate effectively both verbally and in writing with investigators, research teams and colleagues.
The IRB Regulatory Specialist III is primarily responsible for the review and management of a caseload of applications submitted for IRB review. The IRB Regulatory Affairs Specialist III will support the IRB review and approval process and perform the following duties:
making determinations regarding the appropriate type of protocol review;
working independently to conduct pre-review research protocols and assess completeness using
interpreting and applying federal regulations and state laws, institutional policies and guidelines
governing biomedical research to protect human subjects;
ensuring institution maintenance and tracking of regulatory documents using an eIRB protocol
providing consultation to investigators and research teams about institutional and regulatory
assisting human research protection program leadership with drafting policies, FAQs,
educational materials, guidance documents and standard operating procedures to support the institution’s human research protections program.