Clinical Research Associate: On-Site Monitoring & Compliance

ICON Strategic Solutions; Chicago (IL); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Employee assistance program

Job summary

ICON plc in Chicago is seeking a Clinical Research Associate to serve as the primary liaison between investigational sites and sponsors, conducting site visits and ensuring ICH-GCP compliance. You will manage documentation in CTMS and eTMF, monitor patient safety, and support site staff training while coordinating with CTAs, LTMs, and CTMs.

The ideal candidate has a bachelor’s degree in Life Sciences or is a qualified RN, 2+ years of on-site monitoring experience, and can travel up to 50% across

Qualifications

• Bachelor’s degree in Life Sciences or RN qualification.
• Eligible to work in the United States without visa sponsorship.
• 2+ years of on-site monitoring experience in pharma or CRO.
• Experience monitoring multiple therapeutic areas.
• Proficient in ICH-GCP and local regulatory requirements.
• Strong communication, problem-solving and teamwork skills.

Responsibilities

• Serve as the primary liaison between investigational sites and sponsor.
• Conduct site visits: selection, initiation, monitoring, close-out.
• Ensure site compliance with ICH-GCP, SOPs, and regulations.
• Maintain documentation in CTMS and eTMF.
• Track site training and compliance records.
• Monitor patient safety and AE/SAE/PQC reporting.
• Support subject recruitment and retention at sites.
• Oversee drug accountability and storage, return or destruction.
• Resolve data queries and drive timely data entry.
• Escalate risks or issues to the clinical team.

Skills

On-site monitoring

Regulatory compliance

Clear communicator

Problem-solving

Team player

Education

Bachelor's degree in Life Sciences

RN qualification

Tools

CTMS

eTMF

Job description

ICON plc in Chicago is seeking a Clinical Research Associate to serve as the primary liaison between investigational sites and sponsors, conducting site visits and ensuring ICH-GCP compliance. You will manage documentation in CTMS and eTMF, monitor patient safety, and support site staff training while coordinating with CTAs, LTMs, and CTMs.

The ideal candidate has a bachelor’s degree in Life Sciences or is a qualified RN, 2+ years of on-site monitoring experience, and can travel up to 50% across