Clinical Research Associate II

About the role

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.

Responsibilities

• 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 escalate 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

Requirements

• Bachelor’s degree in Life Sciences or equivalent, or a qualified RN
• Eligible to work in the United States without visa sponsorship
• 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry
• Experience monitoring across multiple therapeutic areas
• Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF

Skills

• Clear communicator, problem-solver, and collaborative team player
• Willing and able to travel up to 60%–75% for on-site monitoring visits across the southeast region
• Preference given to candidates residing in Chicago near major HUB airports to support efficient regional travel

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others