General Dynamics IT is currently looking for a Senior Human Subject Protection Specialist to join our team to support our client Defense Health Headquarters (DHHQ) in Falls Church,VA.
The Senior HSPS serve as research regulatory oversight subject matter experts (SMEs) 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).
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.
Provide regulatory-based written reviews of protocols using standardized checklists.
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, including regulatory coordination (work with other regulatory offices to coordinate human subjects protection reviews) as required.
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 and provide a professional quality written review.
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.
Provide support for assurance and HRPP assessments designed to monitor compliance with human subjects protection regulations and make recommendations for improvement.
Support with planning, formulation of agenda, and preparation of materials for use during the visit, to include any educational presentations.
Participate in interviews with investigators, study staff, IRB staff, and institutional officials and conduct detailed policy and regulatory record reviews and assist with preparation of after-action reports.
Support the government in the preparation and staffing of the assurance assessment correspondence and preparing the report findings and travel to sites, as needed, to support the government.
Actively manage and update organizational documentation and information management systems used to track information related to protocol review and assurance oversight, i.e. maintain documents according to document management plan and maintain and track effective dates of agreements and assurances under R2O2 oversight.
Develop and coordinate organizational communications (website, information updates, newsletters, routine correspondence).
Support the government in the development and sustainment of SOPs for the R2O2 and work with components of the OUSD (P&R) to develop and maintain their forms and standard operating procedures.
Coordinate with the USD P&R network of reviewers to address process issues; assist with regulatory interpretation; provide training as needed in new requirements, tools, forms, etc.; and provide other support as needed.
Provide consultation to assist institutions that fall under OUSD P&R oversight to develop and update their human subjects protection policies, procedures, guidelines, templates, and review checklists to ensure regulatory compliance with current laws, regulations, and policies governing human subjects research.
Provide consultation to assist institutions under USD P&R oversight in electronic IRB system submission and use, including training and helpful hints for using the online system, tracking milestones and general system updates, providing research oversight guidance and information.