Clinical Research Associate

ICON plc is a world-leading healthcare intelligence and clinical research organization, and they are seeking a Clinical Research Associate specializing in Oncology. The role involves serving as the primary point of contact between investigational sites and the sponsor, conducting site visits, ensuring compliance, and supporting subject recruitment and retention efforts.

Responsibilities

• Serve as the primary point of contact between investigational sites and the sponsor - Oncology
• 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, 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.

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 oncology clinical trials
• 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 Midwest region; preference given to candidates residing in Detroit near major HUB airports to support efficient regional travel

Required skills

• Adverse Event reporting, CTMS, Clinical site monitoring, ETMF, ICH-GCP, Oncology clinical trials monitoring, Pharmaceutical clinical research, Serious Adverse Event reporting

Experience

• 2+ years