Senior Human Subjects Protection Scientist at CICONIX Frederick, MD

Senior Human Subjects Protection Scientist

CICONIX is seeking a Senior Human Subjects Protection Scientist with Human Subjects Research experience to support the Institutional Review Board (IRB) of the Headquarters of 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) in Ft Detrick, Maryland.

• A comprehensive pre‑review of research protocols and supporting documents before review by a convened IRB or via expedited review procedure.
• Post‑IRB approval lifecycle management of assigned research protocols, including pre‑review of amendments, continuation reports, reports of unanticipated problems/serious adverse events/serious or continuing noncompliance/research suspension or termination/protocol deviations, and final study reports.
• Support for site visits (monitoring, non‑compliance) to include preparation and planning visits, assisting during visits, and preparing written reports.
• Assistance in the development and updating of the IRBs human subjects protection policies, procedures, guidelines, and process improvement initiatives.
• Assistance in developing human subjects protection education and training programs.
• Assistance in the IRB's internal quality control/assurance program.
• Support for the Human Research Protections Office, as needed, to include conducting DoD‑required reviews for USAMRDC-supported research and DoD-conducted research. The individual will work on Ft. Detrick as a member of a team comprised of military, government civil service and contract employees.

Education:

• Bachelor's Degree in Science, Public Health or related discipline

Experience:

• 5+ years direct human subjects research experience supporting either an IRB office or regulatory office.
• Current training in humans subjects protection.
• Proficient in use of Microsoft Word, Outlook, and Excel.
• Ability to effectively communicate with researchers, research staff and IRB members on matters of research compliance and ethical human research practices.
• Ability to quickly become proficient in use of an on‑line document management system and an Oracle-based protocol information management system.

• U.S. Citizenship and a successful background investigation are required.
• Ability to obtain and maintain a government security clearance.

• N/A

$85k - $92k