Clinical Research Associate - Oncology

ICON plc is a world-leading healthcare intelligence and clinical research organization, dedicated to fostering an inclusive environment. They are seeking a Clinical Research Associate to serve as the primary point of contact between investigational sites and the sponsor, ensuring compliance and supporting site activities in oncology clinical trials.

Pharmaceuticals

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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.
• ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services.
• Dublin , GB
• https://www.iconplc.com/services/strategic-solutions/
• Late Stage
• Leadership Team
• Jennifer Alamo Linnell
• VP, Human Resources Business Partner
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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

• CTMS, Clinical Research, Data entry, ETMF, ICH-GCP, Monitoring, Oncology, Regulatory compliance

Preferred skills

• Collaboration, Communication, Problem solving

Experience

• 2+ years