Human Subjects Protection Scientist (IRB)

Seize your opportunity to make a personal impact as a Human Subjects Protection Scientist (HSPS) supporting the Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO) for US Army Medical Research and Development Command (MRDC).

GDIT is your place to make meaningful contributions to challenging projects and grow a rewarding career.

At GDIT, people are our differentiator. As an HSPS you will help ensure today is safe and tomorrow is smarter. Our work depends on an HSPS joining our team to ensure that USAMRDC conducts, contracts, sponsors, supports and manages research investigations involving human subjects, human anatomical substances or animals in accordance with Federal, DoD, Army, USAMRDC, and international regulatory requirements.

HOW YOU WILL MAKE AN IMPACT:

• Provide real-time oversight of USAMRDC-supported research protocols through timely documented reviews of protocol lifecycle actions to ensure ongoing compliance with all applicable Federal, Department of Defense (DoD), Food and Drug Administration (FDA), Department of the Army (DA), state, host nation, and USAMRDC human subjects protection regulatory requirements

• Provide regulatory-based written review and a comprehensive evaluation of protocol life cycle actions (continuing review, amendments/modifications, closures, reports of serious or continuing non compliance, reports of unanticipated problems involving risk to subjects or others, protocol suspension, protocol termination, etc.) using standardized checklists and guidance materials

• Delineate deficiencies and areas of noncompliance and makes recommendations to the OHRO federal AAs regarding regulatory and ethical issues in OHRO post-approval submissions

• Provide accurate information, assistance, and documents to customers and HRPOOHRO 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 and updating the protocol files and the information management systems used to track information and activities related to protocol review

• Support the OHRO federal personnel in the conduct of noncompliance investigations and compliance inspections of extramural protocols.  Employee shall provide regulatory-based written review of OHRO reportable events; includes preparing, planning, conducting, and reporting on compliance inspections of research for which OHRO has oversight

• Assist in the preparation of the written report of each compliance inspection that includes, but is not limited to, documentation/presentation of specific findings of the inspection and recommendations that would enable the institution to bring the research into compliance

• Provide support for staff assistance visits and HRPP assessments designed to monitor compliance with human subjects protection regulations and make recommendations for improvement. This includes assisting with planning, formulation of agenda and preparation of materials for use during the visit, to include any educational presentations

• Prepare staff assistance visit materials (e.g. agenda, checklists, presentation)

• Participate in interviews with investigators, study staff, IRB staff, institutional officials, and research participants, and conduct detailed policy and regulatory record reviews, complete staff assistance checklists, and assist with preparation of after-action reports

• Travel to sites, as needed, to support OHRO Federal personnel to provide compliance oversight to USAMRDC-supported research studies

• 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’LL NEED TO SUCCEED:

• Education: ​Bachelor's degree in Science, Public Health or related discipline
• Required Experience: 1-2 years clinical monitoring experience and/or certification (CCRA or CCRP); 2+ years of related human subjects protection experience

• Required Technical Skills: Experience as a clinical research associate, clinical research coordinator, and/or research assistance are desired; 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

• Security Clearance Level: NACI Clearable

• Required Skills and Abilities: Have excellent interpersonal communication skills and be able to effectively communicate with researchers, research staff and IRB members on matters of research compliance and ethical human research practices

• Location: Hybrid schedule (4 days remote/1 day in office) - Fort Detrick (Frederick, Maryland)

• 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

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