General Dynamics Information Technology Human Subjects Protection Team Lead in Ft Detrick, Maryland
General Dynamics Information Technology – Federal Health Sector is currently looking for an IRB Clinical Research Team Lead to join our team. The position willsupport of theOffice of Research Protections’ Human Research Protections Office (HRPO). This position is based in Ft. Detrick – Frederick, Maryland.
In addition to serving as aHRPO Initial Reviewer(HIR), the Team Lead HSPS shall collaborate with the On-Site Program Manager to manage team workload, monitor and report team productivity, serve an immediate expert resource for all team members and as a mentor for new personnel.
Specific HIR responsibilities include:
Using Government-provided policies, procedures, checklists, and information systems, the Team Lead/HIR shall accelerate an investigator’s pursuit of HRPO approval through timely review of proposal submissions (and associated documents such asresearch 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.
The Team Lead/HIR shall 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 Team Lead/HIR shall provide regulatory-based written initial reviews of protocols using standardized checklists.
The Team Lead/HIR shall 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. On an as-needed basis, the Program Manager may task the Team Lead/HIR to complete review actions for protocols in post-approval oversight.
The Team Lead/HIR shall 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 Team Lead/HIR shall 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 employee shall 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 HIR shall travel to sites, as needed, to support HRPO federal personnel in this task.
The employee shall engage in email and telephone communication with the Principal Investigator and key study personnel to address questions, concerns, and outstanding issues.
- Masters Degree in a scientific discipline.
8-10 years of related experience in scientific research, analysis and/or engineering.
Must be U.S. citizen which will allow and able to obtain NACI clearance.
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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.
Job FunctionScience and Engineering
Security Clearance LevelNone
Full/Part TimeFull Time