Clinical Research Regulatory Affairs Coordinator I

Rush University Medical Center; Chicago (IL); On-site; USD 48,000 - 68,000; Full time

Job summary

Rush University Medical Center in Chicago seeks a Clinical Research Regulatory Coordinator 1 to assist in regulatory documentation for clinical studies under supervision, support IRB submissions, and maintain audit-ready files. The role involves communication with study teams and regulatory stakeholders to ensure timely start-up and ongoing compliance.

The position requires a bachelor’s degree or equivalent and 1+ years in clinical research or healthcare, with knowledge of CFRs, GCP, HIPAA, eIRB

Qualifications

• Education: Bachelor’s degree or equivalent
• Experience: 1+ years in clinical research or healthcare
• Familiarity with CFRs, HIPAA, and eIRB processes

Responsibilities

• Assist with IRB applications, amendments and continuing reviews
• Support submission of regulatory documents to oversight committees
• Maintain audit-ready regulatory files under supervision
• Coordinate with study teams, investigators, and sponsors

Skills

CFR knowledge

HIPAA compliance

eIRB familiarity

Regulatory documentation

Communication

Education

Bachelor’s degree or equivalent

Tools

Microsoft Office

Adobe Acrobat

eIRB systems

Job description

Rush University Medical Center in Chicago seeks a Clinical Research Regulatory Coordinator 1 to assist in regulatory documentation for clinical studies under supervision, support IRB submissions, and maintain audit-ready files. The role involves communication with study teams and regulatory stakeholders to ensure timely start-up and ongoing compliance.

The position requires a bachelor’s degree or equivalent and 1+ years in clinical research or healthcare, with knowledge of CFRs, GCP, HIPAA, eIRB