Senior Clinical Research Administration Manager

Type of Requisition:

Regular

Clearance Level Must Currently Possess:

None

Clearance Level Must Be Able to Obtain:

None

Suitability:

Public Trust/Other Required:

NACLC (T3)

Job Family:

Scientists

Job Qualifications:

Skills:

Clinical Research, Clinical Research Administration, Human Subjects Research, Research Protocols

Certifications:

Experience:

5 + years of related experience

US Citizenship Required:

Yes

Job Description:

GDIT's Military Health team is hiring a Senior Clinical Research Administration Manager to support research within the Air Force- 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 --> https://www.59mdw.af.mil/

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 th