Senior Human Subjects Protection Scientist

Seize your opportunity to make a personal impact as a Senior Human Subjects Protection Scientist supporting support the Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO) for US Army Medical Research and Development Command (MRDC).

At GDIT, people are our differentiator. As a Senior Scientist you will help ensure today is safe and tomorrow is smarter. Our work depends on Scientist joining our team to ensure that USAMRDC conducts, contracts, sponsors, supports managed research and U.S. Army Medical Command investigations involving human subjects, human anatomical substances or animals are conducted in accordance with Federal, DoD, Army, USAMRDC, and international regulatory requirements.

HOW YOU WILL MAKE AN IMPACT:

• 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 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

WHAT YOU’LL NEED TO SUCCEED:

• Education: Bachelor’s Degree in a scientific, or related discipline
• Required Experience: 5+ years of related human subjects’ protection and IRB experience
• Technical Skills and Abilities: Current training in humans subjects protection; Must possess a firm foundation in Federal regulations and ethical principles governing the protection of human research subjects, including the Common Rule and Food and Drug Administration regulations; Knowledge of research concepts to facilitate a detailed review of all types of research protocols submitted for IRB review; Following on-the-job training, must proficiently apply Federal, DOD, Army and USAMRMC human subjects protection regulations, policies and guidelines in the review of research protocols; Ability to quickly become proficient in use of an on-line document management and protocol review system; Proficient in use of Microsoft Word, Outlook, and Excel
• Security Clearance: Clearable for a NACI (T1) security investigation
• Required Skills and Abilities:  Ability to effectively communicate with researchers, research staff, and IRB members on matters of research compliance and ethical human research practices; Ability to write clear, precise, concise, and grammatically correct emails, memos and technical reports; Must possess excellent organizational skills and meticulous attention to detail; Must be flexible and able to prioritize workload to meet the needs of the customer.
• Preferred Skills:  Certified IRB Professional (CIP) or Certified IRB Manager (CIM) preferred

• Location: Ft Detrick (Frederick, Maryland) Hybrid schedule (work 1 day onsite and remainder remote)

• US citizenship required

GDIT IS YOUR PLACE:

• Full-flex work week to own your priorities at work and at home
• 401K with company match
• Comprehensive health and wellness packages
• Internal mobility team dedicated to helping you own your career
• Professional growth opportunities including paid education and certifications
• Cutting-edge technology you can learn from
• Rest and recharge with paid vacation and holidays