Senior Human Subjects Protection Scientist (IRB)

Clearance Level
None
Category
Scientists
Location
Fort Detrick, Maryland

REQ#: RQ136012

Travel Required: 10-25%
Public Trust: NACI (T1)
Requisition Type: Regular

GDIT is HIRING a Senior Human Subjects Protection Scientist 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).

This position is based out of Ft. Detrick in Frederick, Maryland and staff are expected to work on-site 1 day per week (or 2 days per pay period).

The OHARO OHRO is responsible for ensuring that USAMRDC conducts, contracts, sponsors, supports or manages 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.

In this role, the candidate will provide the customer with:

  • 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.

REQUIRED QUALIFICATIONS:

  • Bachelor's Degree in Science, Public Health or related discipline
  • 5+ years of related human subjects protection and IRB experience
  • 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 system and an Oracle-based protocol information management system
  • 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 to include prioritizing workload and maintaining protocol documents and IRB correspondence electronically
  • Must be flexible and able to prioritize workload to meet the needs of the customer while effectively managing assigned portfolio of research protocols
  • Proficient in use of Microsoft Word, Outlook, and Excel
  • US Citizenship and NACI Clearable

PREFERRED QUALIFICATIONS:

  • Certified IRB Professional (CIP) or Certified IRB Manager (CIM) preferred

WHAT GDIT CAN OFFER YOU: 

  • Challenging work that makes a real impact on the world around you  
  • Internal mobility team dedicated to helping you own your career 
  • 401K with company match 
  • Diverse, highly collaborative teams
  • Professional development, education assistance, certification and training opportunities

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About Our Work

We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.

COVID-19 Vaccination

GDIT does not have a vaccination mandate applicable to all employees. To protect the health and safety of its employees and to comply with customer requirements, however, GDIT may require employees in certain positions to be fully vaccinated against COVID-19. Vaccination requirements will depend on the status of the federal contractor mandate and customer site requirements.

GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.

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