Human Subjects Protection (HSP) Administrator

Seize 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 experience
• Required Experience: 2-5 years of related administrative and analytical experience
• Required 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 system
• Security Clearance Level: Ability to pass a T1/ NACI security investigation
• Required 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 practices
• Location: 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 hours
• US Citizenship Required

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

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