Rockefeller University Senior IRB Specialist in New York, New York
Job Title Senior IRB Specialist
Laboratory / Department Hospital
The Rockefeller University Hospital (RUH) comprises a 20-bed inpatient unit and an ambulatory outpatient unit. The RUH mission is to provide a world-class infrastructure and environment for clinical and translational research. The Hospital is staffed 24 hours a day with professional nurses and has nutritional research, social work, art and recreation departments, as well as its own research pharmacy. The staff hospitalist and on-call physicians provide additional medical support to clinical research teams. The RUH receives funding from the National Institutes of Health and other funding sources to support research projects in a variety of focus areas, including addictive diseases, HIV, dermatological diseases, obesity and metabolic diseases and genetic diseases. Human volunteers are vital for the conduct of clinical research and the Rockefeller University Human Research Protection Program (HRPP), which includes the Institutional Review Board (IRB) and other components, exists to assure that research protocols that require human volunteers are carried out in accordance within all relevant ethical and regulatory guidelines and requirements. The HRPP is fully accredited by the American Association of Human Research Protection Programs (AAHRPP). For more information, please see the hospital web site at: http://www.rucares.org/
The Senior IRB Specialist will be responsible for co-managing the daily administrative activities of the Rockefeller University IRB Office, processing all submissions and distribute to IRB members, and providing consultation and instruction on human research regulations and requirements for IRB submissions to members of the RU clinical research community. Will receive all protocol submissions from investigators and oversee the electronic protocol submission and management system, attend IRB meetings and record minutes, pre-review protocols for possible exemption or expedited review, and prepare letters to the investigators outlining the IRB decisions and requirements for modifications. Will collaborate with other members of the RU Human Research Protection Program (HRPP) to develop processes and guidance and standard operating procedures, suggest continuing education for IRB members, and track metrics for turn-around time and ensure that all approvals are granted in a timely manner. Will attend workshops, seminars, and national meetings on human subject research to maintain superior knowledge of IRB regulations and issues, maintain and develop competence in institutional policies and procedures, and participate in quality control activities as appropriate. Will receive and disseminate concerns from research subjects, promote a professional atmosphere through courteous communication, cooperation, and respect for volunteer research subjects, investigators, and other members of the RU community, and observe and respect privacy and confidentiality of information. Will maintain protocol files and databases, help to introduce new IT software and systems to support IRB functions as appropriate, and assist and contribute to the updating of the IRB web site to ensure current information and policies. As Associate Director of the HRPP, the Senior IRB Specialist will also be primarily responsible for maintenance of AAHRPP accreditation, and for updates of the University Human Protection Plan relevant to periodic reaccreditation. Will bear primary responsibility for organizing annual outside reviews and reaccreditation application submissions to AAHRPP, and will conduct the annual IRB member evaluation and appointment process. Will maintain FWA and IRB registration and will serve as a liaison for audits by federal or state regulatory agencies and other regulatory bodies.
Bachelor's degree required; Master's degree preferred. Certification as an IRB Professional (CIP) and a minimum of 3 years of direct relevant operational experience in human subject's research in an IRB support office required. Knowledge of the federal regulations and guidelines pertaining to human subject's research required. Experience working directly with clinical investigators preferred. Must have advanced experience with a relevant electronic protocol submission and management system, including the ability to develop submission forms and troubleshoot IT issues. Must have the ability to analyze and interpret complex information, communicate effectively on all levels, and understand scientific vocabulary. Effective planning and organizational skills, as well as the ability to adjust to changing situations and work assignments necessary. Ability to work with Excel, Word, Adobe and database entry and maintenance required.
The Rockefeller University is an Equal Opportunity Employer - Minorities/Women/Disabled/Veterans