Junior Clinical Trial Regulatory Coordinator

Blue United Sourcing; Chicago (IL); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Benefits eligible

Job summary

The University of Chicago is seeking a Clinical Trial Regulatory Compliance Coordinator to oversee regulatory programs, interpret systems for risk areas, and coordinate internal audits. The role supports documentation, training, and submissions to required committees.

Responsibilities include IRB submissions, regulatory file maintenance, and external site coordination. Requires 2–5 years in clinical research or regulatory affairs and strong communication skills.

Qualifications

• Requires college degree in related field.
• Typically 2–5 years of clinical research or regulatory experience.
• Experience with regulatory submissions and audits.
• Excellent written and interpersonal skills.

Responsibilities

• Prepares and submits materials to IRB and internal review committees.
• Maintains regulatory files for assigned studies and coordinates amendments.
• Communicates protocol changes to the research team and sponsor.
• Participates in internal audits and supports external inspections.
• Acts as regulatory liaison for external sites and coordinates essential documents.
• Activates protocols with consent forms and FDA documentation as needed.
• Coordinates meetings and distributes updates to sites and teams.
• Contributes to compliance plans and supports ongoing training.

Skills

Regulatory compliance

IRB coordination

Audit support

Regulatory documentation

Education

Bachelor's degree in Life Sciences or related field

Tools

MS Office

Adobe Acrobat

IRB systems

Job description

The University of Chicago is seeking a Clinical Trial Regulatory Compliance Coordinator to oversee regulatory programs, interpret systems for risk areas, and coordinate internal audits. The role supports documentation, training, and submissions to required committees.

Responsibilities include IRB submissions, regulatory file maintenance, and external site coordination. Requires 2–5 years in clinical research or regulatory affairs and strong communication skills.