Human Subjects Protection Scientist (HSPS) III - Senior

Overview

LMI is seeking a Human Subjects Protection Scientist III to support the Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO) at Ft. Detrick in Frederick, MD location. The Human Subjects Protection Scientist III leads the reviewing and compliance process for human research protocols, provides regulatory guidance and conducts comprehensive reviews. In this role, you will provide guidance to team members, act as a subject matter expert in Human Subjects Protection and serve as an information resource for the government and investigator's submitting protocols for review for the US Army Medical Research and Development Command (HQ USAMRDC).

This position can be performed hybrid/remotely with onsite requirements 1 day per week. This position requires the ability to pass a T1/NACI security investigation.

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

• Master's degree required. with a minimum of eight (8) years of human research protection experience required.
• Experience in interpreting and applying federal human subjects protection requirements and make regulatory review recommendations.
• Experience in reviewing a variety of research including, but not limited to, research involving human subjects, cadavers, human data, and bio-specimens to ensure compliance with all applicable regulatory requirements.
• Expertise in applying human subject protection requirements to propose potential solutions to facilitate investigators' conduct of compliant research.
• Possess subject matter expertise in human research protection, including application of the Common Rule and subparts B, C and D; HIPAA; and other human research protection regulatory requirements.
• Possess excellent verbal and written communication skills.
• Possess strong analytical, decision-making and creative solving, interpersonal, organizational, and project management skills.
• Have ability to research, obtain, coordinate, and integrate feedback and directions from diverse operational groups and organizations into a written product.
• Have ability to manage multiple projects including planning, problem solving and time-management skills.
• Must be able to work independently in current Microsoft Office Suite products.
• Ability to pass a T1/NACI security investigation.

Target salary range: $81,675 - $130,680

Disclaimer:

The salary range displayed represents the typical salary range for this position and is not a guarantee of compensation. Individual salaries are determined by various factors including, but not limited to location, internal equity, business considerations, client contract requirements, and candidate qualifications, such as education, experience, skills, and security clearances.

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LMI is an Equal Opportunity Employer. LMI is committed to the fair treatment of all and to our policy of providing applicants and employees with equal employment opportunities. LMI recruits, hires, trains, and promotes people without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, pregnancy, disability, age, protected veteran status, citizenship status, genetic information, or any other characteristic protected by applicable federal, state, or local law. If you are a person with a disability needing assistance with the application process, please contact
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