GDIT's Military Health Solutions is hiring a Human Research Protection Support Analyst in support of the Research and Development Directorate (J-9) of the Defense Health Agency located in Silver Spring, MD. The Human Research Protections Analyst will provide support resources which demonstrate knowledge in human research protection and shall assist the HPA with the oversight of research. J-9 delivers value to the military and Veteran communities by shepherding innovative materiel and knowledge products from concept through final product development into the hands of providers and warfighters. We instill best business practices in the creation of these products with the aim to reduce practice variation, enhance pathways of care, improve health, and increase the lethality of a medically ready force.
Learn More About J-9 HERE
Primary Responsibilities to include:
Apply knowledge of human subject protection laws and regulations and supports the Human Protection Regulatory Compliance program for the DHA J9 HRPP.
Assist with development of policy and procedures based upon Federal laws, policies, and guidelines, (32CFR219 National Defense, Protection of Human Subjects, 45CFR46 Department of Health and Human Services, Protection of Human Subjects).
Assist with compliance efforts that ensure that human subjects research may not commence until:
an approved DoD assurance covering the research exists the study has been determined to be scientifically sound 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 the research has been approved for implementation by the Medical Treatment Facility (MTF) Commander or cognizant authority where research is being conducted
Assist the Functional Subject Matter Expert with day to day operations of the J9 Human Research Protection Program (HRPP) Office.
Monitor and provides timely responses for emails in the J9 HRPP group email inbox and consults with the J9 HPA as needed.
Develop a business process for the electronic filing system for J9 HRPP documentation including IRB reviews and J9 HRPP determinations, pre-reviews and regulatory reviews.
Modify and maintain a database to track the lifecycle of J9 human subject research, including IRB reviews and J9 HRPP pre-reviews, determinations and regulatory reviews.
Create and edit spreadsheets, including a spreadsheet that calculates median turnaround times for regulatory reviews.
Maintain electronic filing system for J9 HRPP.
Calculate, compile and submit metrics for J9 HRPP performance measures.
Prepares HRPP briefing slides.
Interface with DHA research sites on an ongoing basis. Facilitates information flow and acts as a liaison between research review boards and Federal and Contractor Principal Investigators, research staff, and administrative staff.
Obtain and files electronic documents for determinations, pre-reviews, IRB reviews and regulatory reviews for J9 research.
Conducts pre-reviews for research involving human subjects and makes preliminary determinations and forwards recommendations to the J9 Human Protections Administrator (HPA).
Communicate with the J9 research investigators to send reminders for timely submission of IRB documents for J9 HRPP review.
Conducts 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.
Maintain working knowledge of HIPAA rules and regulations.
Submit written findings for each assigned Human Research Protection Official review to the J9 HPA.
Conduct administrative and HRPO reviews for human subject research.
Provide support to ensure compliance of DHA research programs with applicable federal, state and local regulations and DoD requirements for human subject research and research involving recombinant DNA.
Track level of efforts and documenting these tasks shall be part of the Monthly Progress Report (MPR).
5+ years of relevant experience.
3+ years of research and regulatory experience.
3+ years of human subjects' protection and IRB experience.
Must have Human Subjects training completed.
Training in human subjects' research protection, animal use, bioethics, and HIPAA required.
Expert level knowledge of human subjects' protection regulations, policies, and guidelines.
Working knowledge of the Common Rule and other regulations/policies relevant to the protection of human subjects, 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
Must have attained or are eligible to attain 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 strongly preferred.
Good written and oral communication skills, along with the ability to work well in team.
Based on contract stipulations, US Citizenship is required with the ability to obtain a favorable T3 security clearance.
For more than 50 years, General Dynamics Information Technology has served as a trusted provider of information technology, systems engineering, training and professional services to customers across federal, state, and local governments, and in the commercial sector. Over 40,000 GDIT professionals deliver enterprise solutions, manage mission-critical IT programs and provide mission support services worldwide. 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.
General Dynamics Information Technology