Clinical Research Associate: On-Site Monitoring & Compliance

Regulatory Jobs; Denver (CO); On-site; USD 91,000 - 114,000; Full time

Benefits offered by this job

Competitive base salary

Health and wellbeing coverage

Retirement plans

Life assurance and disability

Employee assistance programs

Learning and development opportunities

Job summary

ICON Strategic Solutions in Denver is seeking a Clinical Research Associate (Cross Therapeutic Area) to support sponsor-dedicated monitoring across multiple therapeutic areas. You will oversee site visits, ensure ICH-GCP compliance, and maintain CTMS/eTMF documentation while collaborating with cross-functional teams.

The ideal candidate has a Life Sciences Bachelor's or is a qualified RN, 2+ years' on-site monitoring experience, and is willing to travel 60–75% regionally.

Qualifications

• Bachelor’s degree in Life Sciences or RN is required.
• 2+ years of on-site monitoring experience in pharma/CRO.
• Willingness to travel 60–75% regionally, preferably from Denver.

Responsibilities

• Serve as the primary point of contact between investigational sites and the sponsor.
• Conduct site visits including selection, initiation, routine monitoring, and close-out.
• Ensure site compliance with ICH-GCP, SOPs, and regulations.
• Maintain documentation in CTMS and eTMF systems.
• Monitor patient safety and ensure timely AE/SAE reporting.
• Assist in tracking site budgets and payments where applicable.
• Collaborate with cross-functional partners.

Skills

On-site monitoring

Communication

Travel readiness

Education

Bachelor’s degree in Life Sciences

RN qualification

Tools

CTMS

eTMF

ICH-GCP

Job description

ICON Strategic Solutions in Denver is seeking a Clinical Research Associate (Cross Therapeutic Area) to support sponsor-dedicated monitoring across multiple therapeutic areas. You will oversee site visits, ensure ICH-GCP compliance, and maintain CTMS/eTMF documentation while collaborating with cross-functional teams.

The ideal candidate has a Life Sciences Bachelor's or is a qualified RN, 2+ years' on-site monitoring experience, and is willing to travel 60–75% regionally.