What are the responsibilities and job description for the Human Subjects Protection Scientists, IRB Consultants and Staff position at Logistics Management Institute?
Overview
LMI is actively seeking Human Subjects Protection Scientists, Policy Experts, IRB Consultants and Cadaver use Acivity Consultants to support the Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO) at Ft. Detrick in Frederick, MD location.
LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers’ unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.
LMI has been named a 2024 #BestPlacestoWork in the United States by Built In! We are honored to be recognized as a company that values a people-centered culture, and we are grateful to our employees for making this possible!
Responsibilities
- Provides comprehensive, timely review of proposal submissions (and associated documents such as research protocols, consent forms, IRB approvals, and recruitment materials) submitted to ensure compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRDC human subjects protection regulatory and cadaver use requirements.
- Provides regulatory-based written initial reviews of protocols using standardized checklists.
- Formulates and recommends 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 approval.
- Provides human subjects protection regulatory consultation on selected proposals and pre-reviews of draft protocols.
- Conducts pre-reviews of projects submitted for determination of the applicability of the human subjects protection regulations.
- Completes administrative review actions for protocols in post-approval oversight.
- Interprets and applies federal human subjects protection requirements and make regulatory review recommendations for any administrative review action required, from initial submission through lifecycle oversight to study closure.
- Provides accurate information, assistance and documents to customers 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. Actively backups working materials to facilitate review of future actions by team members.
- Responsively engages in email and telephone communication with the Principal Investigator, the Approval Authority, and key study personnel to address questions, concerns, and outstanding issues.
- Trains and mentors new personnel, serves as an immediate expert resource for all team members, and collaborates with leadership to manage team workload.
- All other duties as assigned.
Qualifications
This job posting is for incumbent staff currently supporting the Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO) at the US Army Medical Research and Development Command (MRDC).
Any other applicants to this posting will not be considered for employment on the program at this time; we appreciate your interest in LMI and encourage you to apply to other openings.
