Clinical Research Associate - Cross Therapeutic Area

Regulatory Toolkit; 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

Clinical Research Associate - Cross Therapeutic Area - Denver

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

What You Will Be Doing:

• Serve as the primary point of contact between investigational sites and the sponsor
• Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
• Ensure site compliance with ICH-GCP, SOPs, and regulations
• Maintain up-to-date documentation in CTMS and eTMF systems
• Support and track site staff training and maintain compliance records
• Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
• Support subject recruitment and retention efforts at the site level
• Oversee drug accountability and ensure proper storage, return, or destruction
• Resolve data queries and drive timely, high-quality data entry
• Document site progress and elevate risks or issues to the clinical team
• Assist in tracking site budgets and ensuring timely site payments (as applicable)
• Collaborate with cross-functional partners including CTAs, LTMs, and CTMs

You are:

• A graduate with a Bachelor’s degree in Life Sciences or equivalent, or a qualified RN
• Eligible to work in United States without visa sponsorship
• A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry
• Experienced monitoring across multiple therapeutic areas
• Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
• A clear communicator, problem-solver, and collaborative team player
• Willing and able to travel up to 60% - 75% for on-site monitoring visits across west region; preference given to candidates residing in Denver near major HUB airports to support efficient regional travel

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Salary Range

$91,336.00-$114,170.00