Clinical Research Associate II

ICON is a global healthcare intelligence and clinical research organisation focused on bringing new medicines and treatments to patients faster. The Clinical Research Associate II serves as the primary contact between investigational sites and the sponsor, conducting site monitoring visits, ensuring compliance, supporting patient safety and recruitment, and maintaining high-quality clinical trial data and documentation.

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

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

Company

Outsourced clinical development and commercialization services for life sciences

Dublin , GB

https://www.iconplc.com/services/strategic-solutions/

10001+ employees

Qualifications

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 Midwest region; preference given to candidates residing in Chicago near major HUB airports to support efficient regional travel

Required skills

Clinical Research, On-Site Monitoring, ICH-GCP, Local Regulatory Requirements, CTMS, eTMF, Adverse Event (AE) Reporting, Serious Adverse Event (SAE) Reporting, Patient Recruitment and Retention, Drug Accountability

Experience

2+ years