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.
Job DescriptionSeize your opportunity to make a personal impact as a Human Subjects Protection (HSP) Administrator supporting the Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO) at the US Army Medical Research and Development Command (USAMRDC). GDIT is your place to make meaningful contributions to challenging projects and grow a rewarding career.
At GDIT, people are our differentiator. As an HSP Administrator our work depends on ensuring that USAMRDC conducts, contracts, sponsors, supports or manages research, and U.S. Army Medical Command investigations involving human subjects, human anatomical substances or animals are conducted in accordance with Federal, DoD, Army, USAMRDC, and international regulatory requirements.
HOW YOU WILL MAKE AN IMPACT:
Complete regulatory based reviews of research protocols for continuing review and closure actions
Review IRB approval memoranda and associated materials to ensure local institutional compliance with human subjects regulations
Complete a continuing review checklist to document the IRB regulatory review; draft and send a continuing review acknowledgement memorandum to the Principal Investigator
Complete protocol closure review checklist to document the closure of the protocol; draft closure memos for review by the OHRO Approval Authority
Work independently to obtain the necessary items/documentation needed to compete review items
Prepare additional correspondence related to protocol reviews (emails, requests for information/documentation, acknowledgement emails, etc.)
Manage the assigned protocol portfolio to ensure reviews are up to date, and files/records are complete
Run reports to maintain their portfolio and reach out to investigators every 30 days when information/documentation is needed to complete the review actions
Update OHRO database to track submission and/or review information
Compile reports on pending OHRO reviews as requested
Perform non-routine administrative and analytical tasks in one or more business support functions within the organization
WHAT YOU WILL NEED TO SUCCEED:
Education: Bachelor's degree in Science, Public Health or related discipline or the equivalent combination of education, professional training or work experienceRequired Experience: 2-5 years of related administrative and analytical experienceRequired Technical Skills: Proficiency with Microsoft Office Suite; Ability to become proficient in the use of an electronic document management system and Oracle based protocol information management systemSecurity Clearance Level: Ability to pass a T1/ NACI security investigationRequired Skills and Abilities: Excellent organizational skills, professional conduct and businesslike manner, meticulous attention to detail, committed to helping build and sustain team success; Ability to effectively communicate with researchers, research staff on matters of research compliance and ethical human research practicesLocation: Ft Detrick (Frederick, Maryland) Hybrid schedule - staff expected to work on-site 1 day per week; Staff are expected to be accessible during core hours of 9AM to 3PM, but have flexibility to set their schedule around those core hoursUS Citizenship RequiredGDIT IS YOUR PLACE:
401K with company matchComprehensive health and wellness packagesInternal mobility team dedicated to helping you own your careerProfessional growth opportunities including paid education and certificationsCutting-edge technology you can learn fromRest and recharge with paid vacation and holidays