This position is located in the Office of Human Subjects Research Protections (OHSRP), Office of Intramural Research (OIR), Office of the Director (OD), National Institutes of Health (NIH). The OHSRP is established under the Deputy Director for Intramural Research (DDIR) in order to oversee the Intramural Research Program's (IRP) Human Research Protection Program on behalf of the Deputy Director, who serves as the NIH Human Research Protection Program (HRPP) Institutional Official (IO).
The NIH is located within the Department of Health and Human Services (DHHS) and is the principal medical research agency in the world. Its mission is to provide leadership and direction to biomedical research programs to improve the health of the American people. The NIH conducts and supports research on the causes, diagnosis, prevention, and cure of human diseases, and on the process of human growth and development; supports the training of research personnel; and directs and supports programs for the collection, dissemination, and exchange of information on medicine and health. The NIH consists of an Office of the Director and 27 Institutes and Centers (ICs).
The OHSRP is responsible for the coordination and oversight of the entire NIH human research protection program. This includes formulation and implementation of policies, operation of Institutional Review Board (IRB) and the conduct and operation of compliance and educational training programs, in order to ensure that all research involving human subjects is carried out uniformly at NIH in accordance with the HHS regulations. The NIH Intramural IRB is responsible for the review and approval of all IRP protocols proposed for implementation at the NIH Clinical Center, intramural studies performed at other sites including foreign locations, and for collaborative research involving human subjects proposed by intramural scientists or under the direction of NIH employees regardless of the site of the activity. The IRB Operations Office (IRBO) was established within the OHSRP and is responsible for the management and function of the NIH Intramural IRB and to ensure the rights and welfare of human subjects are adequately protected in accordance with applicable federal, Maryland State (other states as applicable) and local laws and regulations, as well as NIH policies.
Major Duties Summary
The incumbent serves as a Lead Institutional Review Board (IRB) Scientific Analyst, with responsibility for independently providing expertise and scientific, analytical, and program support to the NIH Intramural IRB. The incumbent provides scientific and technical guidance to investigators and institute staff and acts as the responsible point of contact in regard to review of all research activities that are considered not human subjects research, exempt research, non-exempt human subjects research, and human subjects research that requires IRB review at a convened meeting of the full board. The incumbent serves as the primary contact regarding IRB procedures and regulatory requirements for research conducted in the IRP. The incumbent also participates in analyzing and evaluating IRB operations and procedures, in developing and recommending ways to improve their effectiveness and efficiency in meeting regulatory and policy requirements related to human subject protections, and in facilitating the tremendous volume of reviews created by the IRP’s 2500 + active protocols and submission of approximately 150+ new protocols annually.
In addition, a highly qualified candidate will participate in and have experience in the following areas:
Participate in educational activities for IRB professionals and pursues Certified IRB Professional (CIP) certification and continuing education.
Have experience in maintaining and troubleshooting IRB data management systems that comprehensively capture protocol action histories, from scientific review to study completion.
Have knowledge of the regulatory, legal, ethical principles, best practices and NIH policy provisions applicable to protection of human subjects in research, including but not limited to 45 CFR 45 – Protection of Human Subjects (DHHS), 21 CFR Parts 50, 56, 312, 812 (FDA).
Have knowledge of the health or allied health sciences, including technologies, specialties, and personnel requirements, in order to evaluate the impact of medical research protocols on organizational resources and to determine their compliance with regulations and rules governing the conduct of human subjects research.
Have experience in identifying, distributing and balancing workload and tasks among employees in accordance with established IRB work flow, skill level and/or specialization; making adjustments to accomplish the IRB workload in accordance with established priorities to ensure timely accomplishment of assigned team tasks: and ensuring that each employee has an integral role in the success of HRPP.
The Lead IRB Scientific Analyst position being offered is a federal position. For more detailed information about the position and to apply, please follow the link below to USAJOBS. USAJOBS is the Federal Government’s official employment site. The job link will only be open from March 28, 2019 through midnight, April 1, 2019.
The National Institutes of Health (NIH) is one of the world's foremost medical research centers. An agency of the U.S. Department of Health and Human Services, the NIH is the Federal focal point for health and medical research.