Children: National Health System
111 Michigan Avenue, N.W.
Washington, DC 20010
REGULATORY SPECIALIST III : IRB Analyst
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 2015-16. 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:
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). Conducts protocol pre-reviews. Applies knowledge of human subjects protections regulations and institutional policies to manage IRB meetings and provide consultation/education to investigators and research staff. Communicates IRB decisions and rationale to investigators. The assigned job responsibilities require a firm foundation in the guidance and regulations that govern the conduct of research with human subjects.
Requirements for this position include a bachelor’s degree, master’s degree preferred and minimum 3 years work experience. CIP (Certified IRB Professional) is required within a year of starting this position.
Interested candidates should send their resumes to Julia Slutsman by e-mail: email@example.com
We offer a competitive salary and benefits package. Equal Opportunity Employer of Minorities, Females, Protected Veterans, and Individual with Disabilities
Specific Requirements and Preferences
Three to five years experience working in an IRB/Research compliance office with increasing IRB related responsibilities beyond entry level and CIP (Certified IRB Professional) accepted in lieu of bachelor’s degree. If not currently CIP certified, certification must be obtained prior to the end of a 12 month employment term. Minimum 3 years experience in IRB/research administration. Requires three years of research related experience, preferably as an IRB or IACUC administrator.
Strong analytic skills and ability to manage multiple, complex activities while maintaining close attention to detail and meeting required timeframes. Applicants must demonstrate sound judgment, excellent problem-solving, organizational, interpersonal, and time management skills and the ability to communicate effectively both verbally and in writing.
Position requires considerable exercise of professional judgment related to situations of a sensitive, confidential and technical nature. Applicants must have extensive knowledge of research regulations and guidance documents, scientific/medical terminology as well as ability to analyze, comprehend and apply them appropriately to the review of biomedical, social and behavioral sciences research protocols involving vulnerable populations. The RS-III must have ability to maintain balance between ensuring institutional compliance and providing service to investigators.
The IRB Regulatory Specialist II is primarily responsible for the review and management of a caseload of applications submitted for IRB review. The IRB Regulatory Affairs Specialist II will support the IRB review and approval process and perform the following duties: making determinations of the appropriate level of protocol review, pre-review of research protocols of minimal risk and greater than minimal risk; 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 in a comprehensive and time-sensitive manner; providing consultation to investigators and research teams, and assists with drafting policies, guidance documents and standard operating procedures to support the institution’s human research protections program.