GENERAL DYNAMICS INFORMATION TECHNOLOGY Looking for Senior Human Subjects Protection Scientist at Maryland Full Time

GDIT is HIRING a Senior Human Subjects Protection Scientist (HSPS) to support 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).

The OHARO OHRO is responsible for 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
• Work with the investigator to make updates/revisions to the materials to bring the protocol into compliance for OHRO approval
• 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.
• Be assigned a portfolio of protocols for initial review
• Provide accurate information, assistance, and documents to customers and OHRO Federal personnel when requested with appropriate professionalism in a timely manner
• Assist the Government to develop policies, procedures, guidelines, and other materials to ensure compliance with current regulations
• 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
• Support the development and implementation of effective mechanisms to communicate and interpret the 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
• 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
• 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 a scientific, or related discipline
• Required Experience: 3+ years of direct protocol review and human subjects protection experience, 5+ years preferred
• Technical Skills and Abilities: Working knowledge of the Federal regulations and ethical principles governing the protection of human research subjects; Working knowledge of scientific research concepts and terminology to properly conduct detailed analyses of all research protocols submitted for IRB review; Ability to become proficient in the use of an electronic document management system and Oracle based protocol information management system
• Security Clearance: Clearable for a NACI (T1) security investigation
• Location: Ft Detrick (Frederick, Maryland) Hybrid schedule (work 1 day onsite and remainder remote)
• US citizenship required

WHAT GDIT CAN OFFER YOU:

• Challenging work that makes a real impact on the world around you
• Internal mobility team dedicated to helping you own your career
• 401K with company match
• Diverse, highly collaborative teams
• Professional development, education assistance, certification and training opportunities

Work Requirements

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Years of Experience
3 + years of related experience

may vary based on technical training, certification(s), or degree

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Certification

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Travel Required
10-25%

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Citizenship
U.S. Citizenship Required

About Our Work

We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 30 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.

GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.