Seize your opportunity to make a personal impact as a Senior Human Subjects Protection Scientist (HSPS) 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 a Senior HSPS 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:

Provide regulatory-based written review of protocols using standardized checklists to ensure compliance with all applicable Federal, Department of Defense (DoD), Food and Drug Administration (FDA), Department of the Army, state, host nation, and MRDC human subjects protection requirements

This position is tasked with reviewing research protocols that have undergone review and approval by the local Institutional Review Board (IRB); the OHRO reviewer will delineate deficiencies and areas of regulatory noncompliance and make recommendations to the OHRO Federal Approval Authority (AAs) regarding regulatory and ethical issues in OHRO submissions.   The reviewer will work with the investigator to make updates/revisions to the materials to bring the protocol into compliance for OHRO approval

Reviewers will be assigned a portfolio of protocols for initial review; this includes determinations of not research, research not involving human subjects, exempt research, non-exempt research, and protocols utilizing cadavers/cadaveric specimens

Provide accurate information, assistance, and documents to customers and OHRO Federal personnel when requested with appropriate professionalism in a timely manner. *This will require active management of the assigned protocol portfolio; this includes data entry activities and use of OHRO specific information management systems to track information and activities related to protocol review

Assist the Government to develop policies, procedures, guidelines, and other materials to ensure compliance with current regulations and to update investigators, research managers and administrators, and administrative staff on human subjects protection and regulatory compliance policies and procedures as they apply to research supported by the USAMRDC

Assist in the development of local procedures and guidance for the OHRO and the USAMRDC in the area of human subjects’ protection

Support the development and implementation of effective mechanisms to communicate and interpret these regulations, policies, and guidelines

Assist in development and implementation of internal OHRO operating procedures and review guidelines as requested

Foster regulatory compliance through education and training of investigators, research managers, administrators, and OHRO staff, and provide assistance to program offices and investigators with interpretation of human subjects protection and cadaver use requirements

Acquire and retain knowledge of current Federal, DoD, FDA, Army, state, host nation, and USAMRDC regulatory requirements related to the protection of human subjects in research and cadaver use and apply knowledge of these regulations and general ethical principles during OHRO reviews of assigned projects

Interact with colleagues, consultants, investigators, research directors, supervisors, other US Army personnel, etc., to gather or disseminate information or to provide assistance related to assigned protocols, attend meetings and conference calls as necessary, and provide education on human subjects protection regulations and OHRO requirements

Participate in performance improvement activities and shall task contract personnel to participate in specific working groups to improve and streamline the protocol review and approvals processes, and provide input and assistance with formulating and writing OHRO standard operating procedures and work instructions

WHAT YOU WILL NEED TO SUCCEED:

Education: Bachelor's degree in Science, Public Health or related disciplineRequired Experience: 3+ years of related HSP experienceRequired Technical Skills: Must possess a working knowledge of the Federal regulations governing the protection of human research subjects, including a firm foundation in the Common Rule and FDA regulations, to allow for effective and responsible management of a caseload of research protocols submitted for HQ USAMRDC review and oversight; Working knowledge of ethical principles related to participation of humans in research; Working knowledge of scientific research concepts and terminology to properly conduct detailed analyses of all research protocols submitted for IRB review; 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 and IRB members on matters of research compliance and ethical human research practicesPreferred Skills: 5+ years experience preferredLocation: 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 required

GDIT 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

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