Clinical Research Quality Assurance and Improvement Specialist – Ann & Robert H. Lurie Children’s Hospital of Chicago – Chicago, IL

The Clinical Research Quality Assurance and Improvement (QA/QI) Specialist utilizes knowledge to 1) analyze and interpret applicable regulations, 2) develop/revise institutional policies and procedures, 3) audit the conduct of human subjects research (biomedical, social & behavioral) and research oversight programs, 4) assess compliance with all applicable regulations, guidances, and policies and procedures, 5) identify areas of risk, and 6) oversee the development and implementation of corrective and preventive action plans. Ensures adherence to the standards for the responsible conduct of research and compliance. Provides advice and expert knowledge to members of the human research protection program (HRPP). Assists with preparation for external quality reviews and regulatory audits.