Senior Clinical Research Administration Manager

Senior Clinical Research Administration Manager Location San Antonio, TX : Clearance Level None Category Scientists Location San Antonio, Texas Onsite Workplace Public Trust: NACLC (T3) Requisition Type: Regular Your Impact Own your opportunity to work alongside federal civilian agencies. Make an impact by providing services that help the government ensure the well being of U.S. citizens. GDIT's Military Health team is hiring a Senior Clinical Research Administrator in support of the Air Force under the 59th Medical Wing located, on-site, at Lackland Air Force Base in San Antonio, TX. The 59th Medical Wing Science and Technology (ST) office advises and conducts clinical and translational research on matters pertaining to the medical aspects of the Air Expeditionary Force and the health of Air Force (AF) personnel and beneficiaries. In order to support the required research, ST offices conduct translational research in the areas of emergency medical care, combat casualty care, force health protection, restorative medicine, clinical and rehabilitative medicine and specialty centers. Learn More Here - How You Will Make An Impact: ~ Supports the CIRS Office of Protocol Support and Human Protection Administrator (HPA) in oversight of institutional research conducted at the 59th Medical Wing. Manages and provides complex regulatory support of human subjects research, exempt determinations and protocols, animal research, non-human research, etc., with primary emphasis on human subjects research. Works with the HPA, protocol support staff, and investigators in preparing protocols for submission to the San Antonio Institutional Review Board (IRB). Works with the Animal Care and Use Program (ACUP) Clinical Research Administrator and Attending Veterinarian, protocol support staff, and investigators in preparing protocols for submission to the Institutional Animal Care and Use Committee (IACUC) process. Guides and trains investigators in preparing and reviewing protocols, ensuring protocols meet all applicable Defense Health Agency (DHS), DoD, Federal and accreditation requirements. Manages metrics data collection and analysis and oversees the formulation of productivity and other research-related reports. Guides protocol support staff in data collection and report completion. Devises and submits recurring reports to higher headquarters, accrediting agencies, research partners, etc. Advises Human Protections Administrator (HPA) and Branch Chief, Office of Research Protocol Support, on development of processes to review and coordinate all research protocols in accordance with the Revised Common Rule, Belmont Report, Animal Welfare Act and amendments, Public Health Service Policy, other federal, DoD and DHA regulations, and accreditation standards. As required, advises the Animal Care and Use Program Research Administrator/IACUC Chair on development of processes to review and coordinate all research protocols in accordance with the Animal Welfare Act and amendments, Public Health Service Policy, other federal, DoD and DHA regulations, and accreditation standards. Develops and writes operating instructions for all processes associated with regulatory support of research protocols within the institution. Advises on and reviews institutional policies to enable effective implementation of regulatory and DoD policy requirements. Works closely with the Institution's regulatory leads to ensure that all research meets all relevant Federal and DoD regulatory requirements. Supports Exempt Determination Officials and IRB Designated Reviewers in determining category of IRB approval required for studies submitted. Conducts protocol submission administrative reviews, in coordination with the HPA and/or the ACUP Clinical Research Administrator, to ensure all required documents are reviewed and finalized for IRB and/or IACUC review. Manages and tracks all ongoing approval and concurrence actions from Higher Headquarters and coordinates actions with principal investigators and research staff. Establishes procedures for controlling protocol documentation, establishing suspense's, and ensuring documentation is complete and prepared for submission to the appropriate regulatory committee. Tracks training and compliance issues of all individual investigators involved in research, ensuring appropriate training is completed as required, and that all personnel meet compliance regulations pertaining to research being conducted. As required, works with IACUC Chair in conducting meetings for the IACUC. Reviews protocol changes submitted to fulfill IRB required stipulations and assists in approval and concurrence actions from the DHA Office of Research Protection. Conducts training on the DHA's electronic institutional review board System (eIRB) for investigators and research staff. Advises on eIRB system performance and required changes. Compiles protocol records and workload data for periodic DHA and Air Force staff assistance visits, and AAHRPP and AAALAC International accreditation site visits. Participates in site visits as a subject matter expert. In coordination with the HPA, manages and maintains DoD and Federal Wide Assurance documentation and registration. Participates in institutional, Joint Base San Antonio, and DHA-level working group meetings. Plans, executes, and serves as a speaker at the annual Research Fundamentals Workshop. US Citizenship required with the ability to pass a favorable T3 security investigation. What You'll Need (required): Bachelor of Science Degree with at least 5 years of experience in medical research, human subjects research protocol administration OR Master's in a scientific field can substitute for 3 years of required experience. Experience in human subjects research regulatory compliance. Experience and broad knowledge of medical, nursing or allied health care fields used to interpret research functions. Working general knowledge of various medical specialties to thoroughly understand the primary ideas/intent outlined in protocol documents and is able to identify and recommend modifications to correct issues or inconsistencies. Experience or knowledge of research methodology and experimental design to ensure that protocols are properly developed to meet all regulatory compliance guidelines. Experience and ability to clearly articulate objectives, recommendations, and decision, to prepare and present materials and other literature designed for the research process. Effective interpersonal relation skills to diplomatically deal with novice and seasoned researchers in several medical specialties, as well as professionals and staffs at the unit and headquarters levels. Ability to assist in planning, organizing, and administering a variety of programs and activities related to research protocols. Recent knowledge (within 5 years) of human subjects research compliance guidance as outlined in the NIH's Office of Human Research Protections (OHRP) policies and regulations. Knowledge of DoD or DHA guidance and policy, 3 years of human subjects research experience, or Certified IRP Professional credentials can substitute for the OHRP recency requirement. WHAT WOULD BE EVEN BETTER (PREFERRED): PhD Experience in animal research regulatory compliance Recent knowledge (within 5 years) of animal research compliance guidance GDIT IS YOUR PLACE: 401K with company match Comprehensive health and wellness packages Internal mobility team dedicated to helping you own your career Professional growth opportunities including paid education and certifications Cutting-edge technology you can learn from Rest and recharge with paid vacation and holidays #GDITFedHealthJobs #GDITHealth #MilitaryHealthGDITJobs #GDITLabScienceJobs #GDITClinicalResearchJobs #GDITpriority