Clinical Research Associate II

IRE • Chicago, IL

1d • Onsite

About The Position

ICON plc is a world-leading healthcare intelligence and clinical research organization that fosters an inclusive environment. The Clinical Research Associate II role is crucial for shaping the future of clinical development. This position acts as the primary liaison between investigational sites and the sponsor, responsible for conducting various types of site visits including selection, initiation, routine monitoring, and close-out. The CRA II ensures sites adhere to ICH-GCP, SOPs, and regulatory requirements, while also managing documentation, supporting staff training, monitoring patient safety, overseeing drug accountability, resolving data queries, and tracking site progress and budgets. The role involves collaboration with cross-functional partners and requires significant travel for on-site monitoring.

Requirements

• A graduate with a Bachelor’s degree in Life Sciences or equivalent preferred, 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; preference given to candidates residing in Chicago near major HUB airports to support efficient regional travel

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
• Number of Employees: 5,001-10,000 employees