Senior Human Subjects Protection Scientist

Seize your opportunity to make a personal impact as a Senior Human Subjects Protection Scientist supporting the Office of Human Research Oversight (OHARO) who is responsible for ensuring that the United States Army Medical Research and Development Command (USAMRDC) conducts, contracts, sponsors, supports or manages research, and USAMRDC investigations involving human subjects, human anatomical substances or animals are conducted in accordance with Federal, DoD, Army, USAMRDC, and international regulatory requirements.

GDIT is your place to make meaningful contributions to challenging projects and grow a rewarding career. At GDIT, people are our differentiator.

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
• Review research protocols that have undergone review and approval by the local Institutional Review Board (IRB)
• 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.
• Work with the investigator to make updates/revisions to the materials to bring the protocol into compliance for OHRO approval
• 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'LL NEED TO SUCCEED:

• Education: Bachelor's Degree in a scientific, or related discipline
• Required Experience: 5+ years of related human subjects protection experience
• Required Technical Skills: Working knowledge of the Federal regulations governing the protection of human research subjects; 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 system and Oracle based protocol information management system
• Security Clearance Level: Not applicable, but must be clearable for a public trust (NACI-T1)
• Required Skills and Abilities: Must be able to work well in teams and be able to communicate effectively with all levels of staff
• Location: Hybrid position located at Ft Detrick (Frederick) - must be able to work onsite at least 1 day per week
• 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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