General Dynamics Information Technology (www.gdit.com)
GDIT is seeking an experienced Human Subjects Protection Scientist (Initial Reviewer) in support of the Office of Research Protection, based in Fort Detrick, MD.
The Human Subjects Protection Scientist will:
-provide real-time oversight of USAMRMC-supported research protocols through timely documented initial reviews and/or reviews of protocol lifecycle actions to assure ongoing compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRMC human subjects protection regulatory requirements.
-provides regulatory-based written initial reviews or review of protocol life cycle actions using standardized checklists.
-delineates deficiencies and areas of noncompliance and makes recommendations to the HRPO federal AAs regarding regulatory and ethical issues in HRPO 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 will require 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. The contractor shall 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).
-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.
-provide support for the HRPO transition from paper to electronic review processes, including implementation and training on electronic review processes.
-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.
-assist in the development of local procedures and guidance for the HRPO and the USAMRMC in the area of human subjects protection.
-support the development and implementation of effective mechanisms to communicate and interpret these regulations, policies, and guidelines.
-assist in development and implementation of internal HRPO operating procedures and review guidelines as requested.
-foster 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.
-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.
-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.
-participate in performance improvement activities and shall task contract personnel to participate in specific working groups to improve and streamline the protocol review and approvals processes, and provide input and assistance with formulating and writing HRPO standard operating procedures and work instructions.
5-8 years of related experience in scientific research, analysis and/or engineering.
Must possess a working knowledge the Federal regulations governing the protection of human research subjects, including a firm foundation in the Common Rule and FDA regulations, to allow for effective and responsible management of a caseload of research protocols submitted for HQ USAMRMC review and oversight (essential).
Working knowledge of ethical principles related to participation of humans in research (essential).
Working knowledge of scientific research concepts and terminology to properly conduct detailed analyses of all research protocols submitted for IRB review.
Ability to effectively communicate with researchers, research staff and IRB members on matters of research compliance and ethical human research practices.
Following individual training and guidance, ability to become expert at applying DOD, Army and USAMRMC human subjects protection regulations, policies and guidelines.
Demonstrated ability to use all components of Microsoft Office and to write clear, precise, detailed, comprehensive and grammatically correct memos and technical reports (absolute requirement).
Ability to become proficient in the use of an electronic document management system and Oracle-based protocol information management system.
Excellent organizational skills, professional conduct and businesslike manner, meticulous attention to detail, committed to helping build and sustain team success.
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.
1. Bachelors Degree in a scientific discipline.
2. Masters Degree preferred.
Certified IRB Professional (CIP) or Certified IRB Manager (CIM) preferred.