General Dynamics Information Technology Human Subjects Program Manager in Falls Church, Virginia
General Dynamics Information Technology – Federal Civilian Division is currently looking for a Human Subjects Program Manager to join our team. The position will support our client Defense Health Headquarters (DHHQ) in Falls Church, VA. The position will serve as program manager and research regulatory oversight subject matter expert (SME) supporting the Research Regulatory Oversight Office (R2O2) within the Office of the Deputy Assistant Secretary of Defense for Health Readiness Policy and Oversight (HPR&O). Responsibilities shall include:
Provide on-site, day-to-day work supervision of contract personnel assigned to the R2O2. The PM shall also function as a Human Subjects Protection Scientist (HSPS) and shall manage a small caseload of protocols to ensure he/she remains current on process and can provide appropriate guidance to contract staff.
HSPS employees provide comprehensive, timely, professional quality and fully documented reviews of research supported by the components of the USD P&R, including review and determinations for DoD intramural research and Human Research Protection Official Review for extramural research. They formulate and recommend potential solutions to complex problems that would help bring protocols in compliance with the various laws, regulations, policies, procedures, and guidelines governing human subjects research. They provide regulatory-based written review of protocol life cycle actions following a R2O2-required format using standardized checklists. This may include, but not limited to, review of amendments/addenda, continuing review reports, reports of unanticipated problems and serious adverse events, reports of serious or continuing noncompliance, reports of research suspension/termination, protocol deviations, subject complaints, and final study reports. Employees support the government in conducting reviews of assurance requests and site visits, including reviews of standard operating procedures (SOPs) and Institutional Review Board (IRB) records.
The PM shall provide quality assurance oversight for contractor activities and ensure that deliverables meet all timeliness and quality standards.
Ensure that accurate regulatory and procedural guidance are provided in a timely and professional manner.
Assign work to contractor personnel and ensure that all contractor duties are performed in a timely and professional manner and monitor quality of deliverables and workplace performance. The PM shall maintain a positive work environment to facilitate staff success in their job performance.
Provide expert human subjects protection advice to staff when requested.
Ensure continued and up-to-date HSPS professional competency through continuing education and participation in other professional activities.
- Master’s Degree in a scientific discipline.
- Master’s Degree or PhD
- 10-15 years of related experience in scientific research, analysis and/or engineering.
Expert knowledge of human subjects protections required.
Prior experience working with the DoD.
CIP or PMP certification preferred but not required.
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For more than 50 years, General Dynamics Information Technology has served as a trusted provider of information technology, systems engineering, training and professional services to customers across federal, state, and local governments, and in the commercial sector. Over 40,000 GDIT professionals deliver enterprise solutions, manage mission-critical IT programs and provide mission support services worldwide. 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.
Job FunctionScience and Engineering
Security Clearance LevelNone
Full/Part TimeFull Time