General Dynamics Information Technology – Federal Health Sector is currently looking for a Senior Human Research Protection Specialist/Scientist located in Falls Church, VA.
•Provide comprehensive, timely, professional quality and fully documented reviews of research 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 required format using standardized templates. This may include, but not limited to, initial review of new protocols, 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.
•Assess work products for accuracy, timeliness, and adherence to DoD requirements, automated data information system entries and use of the shared computer drive.
•Develop and coordinate organizational communications (website, information updates, newsletters, routine correspondence).
•Strategize with the Federal personnel to improve current processes by developing work instructions, standard operating procedures and standardized forms.
Education Requirements: •Master’s Degree in a scientific discipline.
Experience Requirements: •8+ years of related experience in scientific research, analysis and/or engineering.
•Expert level knowledge of human subjects protection regulations, policies, and guidelines.
•US Citizenship is required, based on government contract stipulations, with the ability to obtain a T3 security investigation.
Internal Number: 53907
About GDIT- Military Health Solutions
As a trusted systems integrator for more than 50 years, General Dynamics Information Technology provides information technology (IT), systems engineering, professional services and simulation and training to customers in the defense, federal civilian government, health, homeland security, intelligence, state and local government and commercial sectors. Headquartered in Fairfax, Va., with major offices worldwide, the company delivers IT enterprise solutions, manages large-scale, mission-critical IT programs and provides mission support services. General Dynamics Information Technology is one of two business units in the General Dynamics Information Systems and Technology business segment.
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