Human Subjects Protection Scientist III

Odyssey is seeking a Human Subjects Protection Scientist III to support the Human Subjects Protection Branch (HSPB) at the Walter Reed Army Institute of Research (WRAIR). The HSPB oversees WRAIR's human research studies, ensuring strict adherence to moral, ethical, and legal standards. The HSPB serves the WRAIR community by advising the Commander on matters related to human subjects research, providing administrative support to the WRAIR Institutional Review Board (IRB), developing human subjects research policies and procedures, and managing the approval process for all research involving human subjects for the WRAIR and its Continental United States (CONUS) and Outside the Continental United States (OCONUS) units.

***Contingent upon contract award***

Duties include, but are not limited to:

The contractor shall provide human subjects protection regulatory and scientific support services via the review of research protocols submitted to the WRAIR, HSPB to include participating in project/protocol development/modification. Human subjects protection regulatory and scientific support services shall include the following tasks:

Evaluate research protocols and protocol lifecycle actions (e.g., amendments, continuing reviews, safety reports, deviations, etc.) for compliance with relevant regulatory requirements and draft a Protocol Evaluation Form (PEF)/pre-review for each action received. PEFs/pre-reviews shall be completed within 15 business days of assignment or within a period of time defined by the COR or HSPB Director. No more than two deviations are acceptable annually.
• Manage the approval process for protocol lifecycle actions by promptly drafting/triaging memoranda within three business days of receipt and obtaining the necessary level of review/approval on behalf of the HSPB, IRB, and WRAIR Command. No more than two deviations are acceptable annually.
• Develop new and recommend revisions to existing policies and procedures at the request of the COR or HSPB Director. Policy revisions and recommendations shall be drafted within ten business days of assignment. The contractor shall complete policy/procedure requests by the due date 95% of the time.
• Attend and participate in seminars, scientific conferences, and meetings pertaining to human subjects protection issues.
• Participate in SAVs to WRAIR and partner laboratories (both CONUS and OCONUS) and draft SAV reports within ten business days following each visit. The contractor shall complete SAV reports by the due date 95% of the time.
• Write communications to Principal Investigators (PIs) to include protocol minutes and excerpts from IRB meetings which shall be provided within four business days after the IRB meeting. The contractor shall complete communications by the due date 95% of the time.

***Contingent upon contract award***

Minimum Required Qualifications

Citizenship: Must be a US citizen

Clearance: NACI (Ability to Obtain)

Education & Years of Experience: Master of Science (MS) in allied sciences with two years IRB regulatory experience; or
Bachelor's degree in allied sciences with five years IRB regulatory experience

Preferred Qualifications

Years of experience: Previous DoD regulatory experience

Additional Information

Location: Silver Spring, MD

Travel: up to 10%

Remote, Onsite, or Hybrid: Hybrid (on-site attendance is generally expected between one and three days per week)

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***Contingent upon contract award***

Odyssey Systems Consulting Group, is an innovative small business committed to providing world-class technical, management, and training support services to government and public sector clients. We focus on people, processes, and performance to deliver superior results. Since our inception in 1997, our commitment to mission success and customer satisfaction has been recognized with exponential growth and exceptional past performance ratings. We accept challenging assignments and drive projects from the planning stages, through implementation, and into operations and support.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Final compensation for this position will be determined by various factors such as the Federal Government contract labor categories and contract wage rates, relevant work experience, specific skills and competencies, geographic location, education, and certifications.

This position is filled through continuous recruitment and will remain open until a sufficient pool of applications has been received.

Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, Tricare supplement, short-term disability, long-term disability, 401(k) match, flexible spending accounts, health savings accounts, employee assistance program, learning and development benefit, paid time off, and holidays.

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