Clinical Research Quality Assurance and Improvement Specialist

Job Overview 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. Job Description Clinical Research Quality Assurance and Improvement (QA/QI) Specialist utilizes knowledge to: Analyze and interpret applicable regulations. Develop/revise institutional policies and procedures. Audit the conduct of human subjects research and oversight programs. Assess compliance with all applicable regulations, guidance, policies and procedures. Identify areas of risk. 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 inspections. Job Responsibilities Utilize expert knowledge to analyze and interpret applicable regulations (federal and local laws, guidance, ICH‑GCP, standards for accreditation, etc.), align, amend, and enforce institutional policies and procedures to protect human research participants. Provide current and accurate compliance information, communicate regulatory changes, and act as a resource to colleagues and researchers. Evaluate compliance by planning and performing monitoring activities (routine and for‑cause audits) to assess risk and ensure adherence to institutional policies, local and federal regulations (OHRP, FDA, etc.) and Good Clinical Practices. Document detailed compliance findings and recommendations with regulatory citations, conduct root‑cause analysis, develop corrective and preventive action (CAPA) plans, and provide targeted education and resources for resolution. Collect data on audit findings, prepare comprehensive QA metrics reports, analyze trends to identify process failures, and direct quality improvement and training initiatives. Present data, trends, and risk assessments to the IRB and the Office of Research Integrity & Compliance. Work with the Clinical Research Educator to develop and deliver educational offerings driven by audit findings (forms, checklists, training, regulatory advice) for investigators, research staff and HRPP members to promote responsible conduct of research. Investigate compliance breaches, gather relevant information, assess impact, determine steps to mitigate risk, and report findings. Assist in the management of external audits by regulatory agencies or business partners. Provide information and services to help research with FDA inspection readiness. Other job functions as assigned. Knowledge, Skills, and Abilities Bachelor's degree in a related field required; master's degree preferred. Minimum of 5 years substantive experience with Phase I–III trials at the Clinical Research Coordinator or Research Compliance Coordinator (IRB Analyst) level; experience at Lurie Children’s preferred. Two years of training or leadership experience preferred. Detailed knowledge of federal, state, and local regulations and ethical principles regarding the protection of human subjects in research. Working knowledge of local and federal regulations for human subjects research (ICH‑GCP, OHRP, FDA). Certification or eligibility to sit for a certification exam in a relevant area (e.g., Certified IRB Professional, Certified Clinical Research Professional, Certified Clinical Research Coordinator/Associate, Society for Quality Assurance, American Society for Quality). Excellent customer service, project management, and process improvement skills; ability to take initiative, prioritize tasks, meet deadlines, and handle pressures. Excellent organizational, analytical, presentation, and training skills. Ability to perform multiple tasks with high accuracy and attention to detail. Proficient computer skills (Excel, Word, Outlook, Access, PowerPoint; electronic medical record EPIC). Education & Compensation Education: Bachelor’s Degree in Biomedical Science (Required). Pay Range: $70,720.00 – $115,627.20. Salary is competitive and aligned with market rates and internal equity. Benefit Statement Full‑time and part‑time employees who work 20 or more hours per week receive a comprehensive benefits package that includes: medical, dental, and vision insurance; employer‑paid group term life and disability; employer contribution toward Health Savings Account; Flexible Spending Accounts; Paid Time Off, Paid Holidays, and Paid Parental Leave; 403(b) with a 5% employer match; and various voluntary benefits (supplemental life, AD&D and disability, critical illness, accident and hospital indemnity coverage, tuition assistance, student loan support, adoption benefits, backup childcare and eldercare, employee assistance program, and behavioral health services for employees and family members). Employees also receive discounts on services at Lurie Children’s facilities and a discount purchasing program. EEOC Statement Lurie Children’s and its affiliates are equal employment opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law. #J-18808-Ljbffr 10 HOSP Ann & Robert H. Lurie Children's Hospital of Chicago