- Using Government-provided policies, procedures, checklists, and information systems, the HRPO Initial Reviewer (HIR) will accelerate an investigator’s pursuit of HRPO approval through timely review of proposal submissions (and associated documents such as research protocols, consent forms, IRB approvals, and recruitment materials) submitted to the USAMRMC to ensure compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRMC human subjects protection regulatory and cadaver use requirements.
- HIR will provide comprehensive, timely, professional quality and fully documented initial reviews of research supported by the USAMRMC. The purpose of these reviews is to assure compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRMC human subjects protection and cadaver use regulatory requirements and to delineate deficiencies and areas of noncompliance. These reviews support recommendations regarding regulatory and ethical issues for submission that are provided to the Principal Investigator following review and approval by the HRPO Approval Authority. The HIR will provide regulatory-based written initial reviews of protocols using standardized checklists.
- The HIR will 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 and cadaver use. This includes identification and assessment of noncompliance when the research is conducted prior to HRPO approval.
- The HIR will 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 of the protocol files and the information management systems used to track information related to protocol review. This also requires active backup of HSPS working materials to the HRPO’s shared computer drive to facilitate review of future actions by team members
- The HIR will 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. The PIR will participate in interviews with investigators, study staff, IRB staff, institutional officials, and research participants, and conduct detailed policy and regulatory record reviews and assist with preparation of after-action reports. The PIR will travel to sites, as needed, to support HRPO federal personnel in this task.
- The HIR will provide support for the HRPO transition to new electronic review and achival processes; this support will include testing implementation and provision of training on electronic review processes.
- The HIR will engage in email and telephone communication with the Principal Investigator and key study personnel to address questions, concerns, and outstanding issues.
- The HIR will assist the Government to develop policies, procedures, guidelines, and other materials to ensure compliance with current regulations and to update investigators, research managers and administrators, and administrative staff on human subjects protection and regulatory compliance policies and procedures as they apply to research supported by the USAMRMC.
- The HIR will assist in the development of local procedures and guidance for the HRPO and the USAMRMC in the area of human subjects protection. The contractor shall support the development and implementation of effective mechanisms to communicate and interpret these regulations, policies, and guidelines. The HIR will assist in development and implementation of internal HRPO operating procedures and review guidelines as requested.
- The HIR willfoster regulatory compliance through education and training of investigators, research managers, administrators, and HRPO staff, and provide assistance to program offices and investigators with
- interpretation of human subjects protection and cadaver use requirements. The contractor shall provide planning assistance and support for meetings and training/conferences sponsored by the ORP.
- The HIR will acquire and retain knowledge of current Federal, DoD, DA, state, host nation, and USAMRMC regulatory requirements related to the protection of human subjects in research and cadaver use and apply knowledge of these regulations and general ethical principles during HRPO reviews of assigned projects.
- The HIR will interact with colleagues, consultants, investigators, research directors, supervisors, other US Army personnel, etc., to gather or disseminate information or to provide assistance related to assigned protocols, attend meetings and conference calls as necessary, and provide education on human subjects protection regulations and HRPO requirements.
- The HIR will present appropriate training sessions targeted for Commanders, institutional officials, investigators, research managers and administrators, and administrative staff, as needed. The contractor shall prepare appropriate training packets and other materials for training.
- The HIR will actively manage and update protocol files and the information management systems used to track information related to protocol review, i.e., contractor personnel must master entry of protocol-related information into automated information management systems, and keep protocol status and event information complete and up to date. The contractor shall assess the contractor work products for accuracy, timeliness, and adherence to ORP requirements regarding regulatory reviews, electronic information system entries, and use of the shared computer drive. The HIR will assist in the execution of an internal quality control/assurance program. The HIR will provide periodic reports of workload management and review throughput in accordance with HRPO guidance.
Bachelors Degree in a scientific discipline.
5-8 years of related experience in scientific research, analysis and/or engineering. IRB and/or clinical experience preferred. 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.