Department of Health and Human Services (HHS) National Institutes of Health (NIH) National Cancer Institute (NCI) Division of Cancer Treatment and Diagnosis (DCTD) Position Description: The National Cancer Institute (NCI) is recruiting for a Central Institutional Review Board (CIRB) Expert in the Clinical Trials Operations and Informatics Branch (CTOIB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI). The CTOIB is part of the Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), which is an extramural division of the National Cancer Institute (NCI), National Institutes of Health (NIH). This is a full-time government position in Rockville, Maryland. The NCI sponsors and funds a broad range of clinical trials for children and adults with cancer through a variety of clinical trials groups and consortia. Through these programs, NCI works collaboratively with clinical investigators in NCI-funded clinical trial networks, often in collaboration with pharmaceutical industry partners, to optimize the development of cancer treatments in the public interest and to increase understanding of the cancers being studied. the Clinical Trials Operations and Informatics Branch (CTOIB) coordinates the development, implementation, and conduct of all clinical trials management processes and informatics tools specific to the operations of CTEP s overall clinical trials portfolio. The broad scientific reach of this nationwide program requires that CTOIB staff interact with multiple NCI programs, including National Clinical Trials Network (NCTN), Experimental Therapeutics Clinical Trials Network (ETCTN, NCI Community Oncology Research Program (NCORP), Cancer Centers, and specialized Consortia grantees. This coordination role of CTOIB extends across NCI Divisions and Centers to involve all major NCI Divisions (especially DCP and DCCPS), CCT and CBIIT, and the Cancer Centers program. CTOIB staff interacts frequently with the lead investigators and administrative staff within networks and consortia, especially the Clinical Trials Cooperative Group Program. The Cooperative Group Program enrolls approximately 25,000 patients annually and provides a mechanism for the continuous generation of therapeutic and ancillary studies with the intent of improving the survival and quality of life of patients afflicted with cancer in the U.S. and worldwide. Since 1999, CTEP has been responsible for creating and managing the NCI Central Institutional Review Board (CIRB). The CIRB was created to reduce the redundant and costly Institutional Review Board (IRB) review of multi-center phase 3 Cooperative Group trials by centralizing the review function in a single Review Board, while maintaining an excellent standard of human subjects’ protection. The CIRB is a complex project that involves over 300 sites across the U.S. The candidate will Serves as Senior Health Scientist with overall responsibility for the development, implementation, and daily operation of the CIRB initiative. Serves as a technical authority, senior advisor, and consultant in the field of clinical research and human subjects protection. Serves as the principal resource in the office of the NCI CIRB in developing research policy, particularly, in the area of protecting the human subjects of research. Responsible for conceiving, formulating, and establishing criteria and objectives which ensure CIRB accreditation. Provides leadership, expert advice, and direction on accreditation program requirements and procedures. Plans and conducts program reviews to evaluate the effectiveness of the contract to ensure that it meets the criteria and is in compliance with regulations and laws. Serves on committees established to review proposed regulations, guidelines, and procedures. Additional details of the CTOIB can be accessed at: https://ctep.cancer.gov/branches/cib/default.htm.
Candidates must be US citizens and have successfully completed a bachelor’s or graduate/higher level degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. Skills in advising, serving as a recognized authority and consultant, and providing direction and guidance to major initiatives affecting the NCI clinical trials program; advanced skills in the regulations and best practices associated with the management and operations of IRBs for biomedical research programs, and specifically those involving cancer treatment and development; and knowledge of clinical research, especially as it relates to the design and conduct of clinical trials, including knowledge of current oncologic therapeutics, disease sites, drug therapy, drug toxicities, patient management, and investigational therapies, are desired. Salary will be commensurate with experience. A full civil service package of benefits (including health insurance, life insurance, and retirement) is available.
