We are GDIT. As one of the largest IT and mission services providers to the government, we own our opportunities to better enable healthcare organizations to identify theirs.
GDITs Military Health Solutions is hiring a Human Research Protection Subject Matter Expert in support of the Research and Development Directorate (J-9) of the Defense Health Agency located in Silver Spring, MD. The Human Research Protection SME will provide support resources which demonstrate knowledge in human research protection and shall assist the HPA with the oversight of research.
In this role, a typical day will include:
Applying expert knowledge of human subject protection laws and regulations
Assisting with development of policy and procedures based upon Federal laws, policies, and guidelines, (32 CFR 219 National Defense, Protection of Human Subjects, 45 CFR 46 Department of Health and Human Services, Protection of Human Subjects)
Assisting with compliance efforts that ensure that human subjects research may not commence until an approved DoD assurance covering the research exists
Making sure the study has been determined to be scientifically sound
Confirming the research has been approved by the Institutional Review Board (IRB) of record or the HPA has deemed that the activity is exempt from the provisions of 32 CFR 219
Verifying the research has been approved for implementation by the Medical Treatment Facility (MTF) Commander or cognizant authority where research is being conducted
Providing expert guidance regarding ethical foundations, DoD and other Federal regulations, regulatory compliance, Good Clinical Practice (GCP) and clinical trials standards, other research standards for all aspects of human subject research regardless of discipline
Monitoring and provides timely responses for emails in the J9 HRPP group email inbox and consults with the J9 HPA as needed
Developing a business process for the electronic filing system for J9 HRPP documentation including IRB reviews and J9 HRPP determinations, pre-reviews and regulatory reviews
Formulating and recommending potential solutions to complex problems that would help bring protocols in compliance with the various laws, regulations, policies, procedures, and guidelines governing human subjects’ research, including regulatory coordination (work with other regulatory offices to coordinate human subjects’ protection reviews) as required
Educating the institution’s staff to maintain a culture of compliance with all Department of Defense (DoD) regulations and institutional policies and procedures relevant to the protection of human subjects
Providing a working knowledge of HIPAA rules and regulations and reports any HIPAA violations to DHA Privacy Officer
Modifying and maintaining a database to track the lifecycle of J9 human subject research, including IRB reviews and J9 HRPP pre-reviews, determinations and regulatory reviews
Calculating, compiling and submitting metrics for J9 HRPP performance measures
Facilitating information flow and acting as a liaison between research review boards and Federal and Contractor Principal Investigators, research staff, and administrative staff
Obtaining and filing electronic documents for determinations, pre-reviews, IRB reviews and regulatory reviews for J9 research
Conducting pre-reviews for research involving human subjects and makes preliminary determinations and forwards recommendations to the J9 Human Protections Administrator (HPA)
Conducting regulatory reviews for the post-IRB approval lifecycle management of research including new studies, continuing reviews, amendments, unanticipated problems involving risks to subjects or others, serious adverse events, continuing noncompliance, serious noncompliance, research suspensions, research terminations, protocol deviations, investigations and audits of J9 human subject research, and study closures. Submits written findings for each assigned Human Research Protection Official review to the J9 HPA.
Ensuring prompt reporting of noncompliance as applicable and seeks corrective action
Developing and coordinating organizational communications (website, information updates, newsletters, town halls, HPA monthly meetings and routine correspondence)
Conducting administrative and HRPO reviews for human subject research
Providing support to ensure compliance of DHA research programs with applicable federal, state and local regulations and DoD requirements for human subject research
Assisting the HPA with oversight of research involving recombinant DNA
Analyzing user needs and performs research and functional analysis on a variety of projects
Masters degree in related discipline
8+ years of related experience in scientific research, analysis, and/or engineering
5+ years of regulatory experience
5+ years of human subjects’ protection and IRB experience
Training in human subjects’ research protection, animal use, bioethics, and HIPAA required
Expert level knowledge of human subjects’ protection regulations, policies, and guidelines
Ability to serve as the subject matter expert in required areas of expertise and provide industry best practice solutions to extremely complex problems being addressed
Ability to obtain a favorable NACLC (T3) investigation
PhD degree in related discipline
10+ years of related experience in scientific research, analysis, and/or engineering
Prefer certification as a Certified IRB Professional (CIP), Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA)
Prior experience within the DoD/VA systems of care
WHAT GDIT CAN OFFER YOU:
401K with company match
Internal mobility team dedicated to helping you own your career
Collaborative teams of highly motivated critical thinkers and innovators
Ability to make a real impact on the world around you
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COVID-19 Vaccination Requirement: To protect the health and safety of its employees and to comply with customer requirements, 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.
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.