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 polies, procedures, guidelines, and process improvement initiatives
Assistance in developing human subjects protection education and training programs
Assistance in the IRBs 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.
Bachelors 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
Certified IRB Professional (CIP) or Certified IRB Manager (CIM) preferred
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.
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.