Clinical Research Quality Assurance and Improvement Specialist

Ann & Robert H. Lurie Children’s Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do. Ann & Robert H. Lurie Children’s Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report.

Simpson Querrey Biomedical Research Center

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.

Essential Job Functions:

1. Utilizes expert knowledge to analyze and interpret applicable regulations (federal and local laws, guidances, ICH -GCP, standards for accreditation, etc.), align, amend and enforce institutional policies and procedures and protect human research participants. Provides current and accurate compliance information and resources to the research community. Communicates regulatory changes, updates procedures according to best practices, and acts as a resource to colleagues and researchers in the area of research compliance.

2. Evaluates compliance by planning and performing monitoring activities (i.e., routine and for-cause audits) in order to assess risk and ensure adherence to institutional policies and procedures, local and federal regulations (i.e., OHRP, FDA, etc.) and Good Clinical Practices (ICH-GCP). Develops and maintains quality assessment standards, tools, policies, and procedures needed to perform internal assessments of the conduct of clinical research at the institution.

3. Documents detailed compliance findings and recommendations (with regulatory citations) in a timely manner that allows for proper review and assessment of the risks identified (including root cause analysis) and the conclusions drawn. Exercises appropriate judgment in evaluating audit findings, develops corrective and preventive action (CAPA) plans, provides targeted education and resources for resolution in a collegial and educational manner. Assists research teams in resolving issues and ensures responses and corrective and preventative action plans are implemented in a timely manner.

4. Collects data on audit findings, prepares comprehensive reports (QA metrics) and analyzes trends to identify process failures and direct quality improvement and training initiatives. Presents data, trends, and risk assessments to the IRB and the Office of Research Integrity & Compliance.

5. Works with Clinical Research Educator to develop and deliver educational offerings driven by audit findings (e.g. forms and checklists, educational training, regulatory advice/consultation, etc.) for investigators, research staff and other members of the HRPP to promote the responsible conduct of research and assists with site or study-specific self-assessments.

6. Investigates compliance breaches, gathers relevant information, assesses impact, determines steps to mitigate risk, and reports findings.

7. Assists in the management of external audits by regulatory agencies or business partners. Provides information and services to help research with FDA inspection readiness.

8. Other job functions as assigned.

Knowledge, Skills and Abilities:

1. Bachelor’s degree in a related field required. Master’s degree preferred.

2. A minimum of 5 years substantive experience with Phase I though Phase