Senior Human Research Protection Specialist
- Military veterans preferred
2019-05-12 General Dynamics Information Technology (www.gdit.com)
Falls Church Virginia United States
General Dynamics Information Technology – Federal Health Sector is currently looking for a Senior Human Research Protection Specialist to join our team to support our client Defense Health Headquarters (DHHQ) in Falls Church,VA. The position will 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.
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, 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.
Support for the conduct of site visits to customer institutions to monitor compliance with approved protocols from institutions that fall under OUSD P&R oversight and assist government with investigating and resolving unanticipated problems and allegations of noncompliance. This includes preparing, planning, conducting, and reporting on compliance inspections of research for which the OUSD P&R has oversight. Also provide completed site visit/inspection checklists, written findings from site visit and compliance inspection activities.
Assist in the preparation of the written report of each compliance inspection that includes written specific findings of the inspection. Suggest an action plan to address the deficiencies in the report and follows-up to ensure the deficiencies are addressed in a timely manner and travel to sites, as needed, to support federal personnel in compliance oversight of protocols.
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.
Assess work products for accuracy, timeliness, and adherence to R2O2 requirements, automated data information system entries and use of the shared computer drive.
Develop and coordinate organizational communications (website, information updates, newsletters, routine correspondence).
Support the Quality Improvement initiatives of the R2O2.
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.
8-10 years of related experience in scientific research, analysis and/or engineering.
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.
Masters Degree in a scientific discipline.
Expert level knowledge of human subjects protection regulations, policies, and guidelines.