Research Protection Quality Assurance Analyst, DOD Health

ASRC Federal•Falls Church, VA

About The Position

ASRC Federal is seeking a Research Protection Quality Assurance/Quality Improvement (QA/QI) Analyst in the field of human/animal research protection with experience in compliance, oversight, regulatory, research integrity or similar role/function. We offer an excellent benefits package and foster a culture of innovation, continuous improvement and recognition for results.

Requirements

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.

Nice To Haves

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

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).