Human Subjects Protection Scientist

Seize your opportunity to make a personal impact as a Human Subjects Protection Scientist supporting support 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 a Scientist you will help ensure today is safe and tomorrow is smarter. Our work depends on Scientist joining our team to ensure that USAMRDC conducts, contracts, sponsors, supports managed 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 A SCIENTIST 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 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 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 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 guideline

• 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 a scientific, or related discipline
• Required Experience: 2+ years of related human subjects protection experience
• Required 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; Following individual training and guidance, ability to become expert at applying DOD, Army and USAMRDC human subjects protection regulations, policies and guidelines; Proficiency with Microsoft Office Suite; Ability to become proficient in the use of an electronic document management and review 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, and IRB members on matters of research compliance and ethical human research practices
• Location: Hybrid, on Fort Detrick worksite (Frederick, MD); staff are expected to work onsite 1 day per week and will need to be accessible during core hours of 9am to 3pm M-F, but have the flexibility to set their schedule around these core hours
• US Citizenship Required

GDIT IS YOUR PLACE:

• Full-flex work week to own your priorities at work and at home
• 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