Human Research Protection Subject Matter Expert

Clearance Level
None
Category
Scientists
Location
Silver Spring, Maryland

REQ#: RQ106094

Travel Required: Less than 10%
Public Trust: NACLC (T3)
Requisition Type: Regular

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

REQUIRED QUALIFICATIONS:

  • 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
  • US Citizenship
  • Ability to obtain a favorable NACLC (T3) investigation 

PREFERRED QUALIFICATIONS:

  • 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

Not sure this job’s the one for you? Check out our other openings at gdit.com/careers.

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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.