- Provide real-time oversight of USAMRMC-supported research protocols through timely documented reviews of protocol lifecycle actions to assure ongoing compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRMC HSP regulatory requirements. Provide regulatory-based written review of protocol life cycle actions using standardized checklists. Delineate deficiencies and areas of noncompliance and makes recommendations to the HRPO federal AAs regarding regulatory and ethical issues in HRPO post-approval submissions.Provide a comprehensive review and evaluation of protocol amendments/addenda, continuing review reports, reports of unanticipated problems and serious adverse event, 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, as required.Provide accurate information, assistance, and documents to customers and HRPO federal personnel when requested with appropriate professionalism in a timely manner. This requires active management and updating the protocol files and the information management systems used to track information related to protocol review.
Support the HRPO federal personnel in the conduct of noncompliance investigations and compliance inspections of extramural protocols. Also provide regulatory-based written review of HRPO reportable events. Support includes preparing, planning, conducting, and reporting on compliance inspections of research for which HRPO has oversight. Assist in the preparation of the written report of each compliance inspection that includes, but is not limited to, written specific findings of the inspection and recommendations that would enable the institution to bring the research into compliance.Provide support for staff assistance visits and HRPP assessments designed to monitor compliance with human subjects protection regulations and make recommendations for improvement. This includes assisting with planning, formulation of agenda and preparation of materials for use during the visit, to include any educational presentations. Prepare staff assistance visit materials (e.g. agenda, checklists, presentation). Also participate in interviews with investigators, study staff, IRB staff, institutional officials, and research participants, and conduct detailed policy and regulatory record reviews, complete staff assistance checklists, and assist with preparation of after-action reports. Travel to sites, as needed, to support HRPO federal personnel to provide compliance oversight to USAMRMC-supported research studies.Submit weekly reports to Team Leader documenting actions completed
Bachelors Degree in a scientific discipline.
- 2-5 years of related experience in scientific research, analysis and/or engineering.
- Must be a U.S. citizen. / Must be able to obtain a National Security Clearance.
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.With approximately 32,000 professionals worldwide, the company delivers IT enterprise solutions, manages large-scale, mission-critical IT programs and provides mission support services.GDIT is an Equal Opportunity/Affirmative Action Employer - Minorities/Females/Protected Veterans/Individuals with Disabilities.