Senior Clinical Research QA & Quality Improvement

Lurie Children's; Chicago (IL); On-site; USD 70,720 - 115,627; Full time

Benefits offered by this job

Medical, dental and vision insurance

PTO and paid holidays

Paid parental leave

403(b) with 5% employer match

Educational assistance

Job summary

Ann & Robert H. Lurie Children’s Hospital of Chicago seeks a Clinical Research Quality Assurance and Improvement Specialist to ensure compliance with federal, state, and local regulations governing human subjects research. You will plan audits, identify risks, develop CAPA plans, and educate research teams on best practices.

The role requires knowledge of ICH-GCP, FDA regulations, and IRB processes. Strong analytical, communication, and project management skills are essential for advancing

Qualifications

• Bachelor’s degree in Biomedical Science (Required).
• Master’s degree preferred.
• Detailed knowledge of federal, state, and local regulations and ethical principles regarding protection of human subjects in research.
• Working knowledge of local and federal regulations for human subjects research (ICH-GCP, OHRP, FDA).
• Certification eligibility for IRB/QA certifications (PRIM&R, SOCRA, ACRP).

Responsibilities

• Analyze and interpret applicable regulations and align/amend institutional policies and procedures.
• Plan and perform monitoring activities (audits) to assess risk and ensure compliance.
• Document findings with regulatory citations and develop CAPA plans.
• Collect data on audit findings and prepare QA metrics and trend analyses.
• Present risk assessments and findings to IRB and Office of Research Integrity & Compliance.
• Develop and deliver educational offerings based on audit findings for investigators and staff.
• Assist in external regulatory audits and FDA inspection readiness.
• Perform additional duties as assigned.

Skills

Regulatory compliance

QA audits

CAPA processes

Risk assessment

IRB knowledge

FDA/ICH-GCP

Data analysis

Communication skills

Project management

Education

Bachelor’s degree in Biomedical Science

Master’s degree preferred

Tools

Excel

Word

Outlook

Access

PowerPoint

EPIC

Job description

Ann & Robert H. Lurie Children’s Hospital of Chicago seeks a Clinical Research Quality Assurance and Improvement Specialist to ensure compliance with federal, state, and local regulations governing human subjects research. You will plan audits, identify risks, develop CAPA plans, and educate research teams on best practices.

The role requires knowledge of ICH-GCP, FDA regulations, and IRB processes. Strong analytical, communication, and project management skills are essential for advancing