Clinical Research Associate II

ICON plc • Chicago, IL

1d • Onsite

About The Position

ICON plc is a world-leading healthcare intelligence and clinical research organization, fostering an inclusive environment for innovation and excellence in clinical development. This role serves as the primary point of contact between investigational sites and the sponsor, conducting various site visits including selection, initiation, routine monitoring, and close-out. The associate ensures site compliance with ICH-GCP, SOPs, and regulations, maintains documentation in CTMS and eTMF systems, and supports site staff training. Key responsibilities also include monitoring patient safety, supporting subject recruitment and retention, overseeing drug accountability, resolving data queries, and documenting site progress. The position requires collaboration with cross-functional partners and may involve assisting with site budgets and payments. ICON is committed to a diverse culture that rewards high performance, nurtures talent, and is dedicated to conducting business sustainably and supporting communities.

Requirements

• 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
• Experience monitoring Oncology clinical trials required, preferably heme/onc
• 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 50% for on-site monitoring visits across southeast region

Nice To Haves

• Bachelor’s degree in Life Sciences or equivalent preferred
• Preference given to candidates residing in Chicago near major HUB airports to support efficient regional travel

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

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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level