The Clinical Research Quality Assurance and Improvement (QA/QI) Specialist provides quality improvement support through the analysis and application of regulations, policies and procedures related to human subjects research. This includes conducting routine and for-cause audits of the Human Research Protections Program (HRPP) (biomedical, social & behavioral) and research oversight programs and assists with the development and implementation of corrective and preventive action plans. Regulatory Knowledge and Scientific Design Utilizes expert knowledge to analyze and interpret applicable regulations (federal and local laws, guidance, ICH-GCP, standards for accreditation, etc.), align, amend and enforce institutional policie