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ASRC Federal · 1 day ago

Research Protection Quality Assurance Analyst, DOD Health

Falls Church, VA

Full-time

Onsite

Mid Level

ASRC Federal is a leading government contractor furthering missions in space, public health and defense. They are seeking a Research Protection Quality Assurance Analyst to provide quality assurance program analysis and support for the DoD Defense Health Agency's human research protections.

ConsultingGovernmentInformation TechnologyLogisticsProfessional ServicesSpace TravelStaffing Agency

No H1B

Security Clearance Required

U.S. Citizen Only

Responsibilities

Provide quality assurance program analysis and support for the DoD Defense Health Agency (DHA) Component Office for Human Research Protections (COHRP), and Component Office for Research Integrity and Misconduct (CORIM). These Components provide oversight and guidance to the human research protection programs (HRPPs) at military medical and dental treatment facilities

Provide subject matter expertise in implementation of/ensuring compliance with 32 Code of Federal Regulations (CFR) part 219, 45 CFR part 46 Subparts A-E, 21 CFR parts 50 and 56, DoD Instructions 3216.01 and 3216.02, 10 United States Code part 980, and other applicable Federal, State, and local regulations

Coordinate with reviewers to address process issues; provide support with regulatory interpretation; provide training as needed in new requirements, tools, and forms

Support the government in the conduct of formal and informal reviews of the actions taken by research review systems including IRBs, Human Research Protection Officials, and Exemption Determination Officials (EDOs)

Qualification

Lean Six SigmaHuman/Animal Research ProtectionCompliance OversightRegulatory KnowledgeResearch Integrity

Required

Minimum Bachelors degree

Lean Six Sigma certificate or related quality/process improvement type certification

Must be a US Citizen with ability to obtain a Secret level clearance

Ability to successfully pass a DHA background investigation

Preferred

Preferred experience working in a human/animal research protection environment, preferably in a compliance, oversight, regulatory, research integrity, or advisory role