Clinical Research Associate - Cross Therapeutic Area

ICON Strategic Solutions is a sponsor-dedicated clinical research organization supporting pharmaceutical and CRO sponsors in developing treatments. The Clinical Research Associate will manage investigational site relationships, conduct monitoring visits across therapeutic areas, ensure regulatory and data compliance, support patient safety and recruitment, and collaborate with clinical teams.

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
• 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
• Remote work arrangement

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

Required skills

• CTMS, Clinical Site Monitoring, ETMF, ICH-GCP, Local Regulatory Requirements, Multi-Therapeutic Area Clinical Research

Experience

• 2+ years