Senior Clinical Research Associate

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Logo of ICON plc

ICON plc

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Serve as the primary point of contact between investigational sites and the sponsor • Conduct site selection, initiation, routine monitoring, and close-out visits • Ensure site compliance with ICH-GCP, SOPs, and regulations • Maintain documentation in CTMS and eTMF systems • Support and track site staff training and compliance records • Monitor patient safety and ensure timely AE/SAE/PQC reporting • Support subject recruitment and retention at site level • Oversee drug accountability and 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 • Track site budgets and ensure timely site payments as applicable • Collaborate with CTAs, LTMs, CTMs, and other cross-functional partners

🎯 Requirements

• Bachelor’s degree in Life Sciences or equivalent, or qualified RN • Eligible to work in the United States without visa sponsorship • 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry • Experience across multiple therapeutic areas, ideally including Oncology and Hematology • Oncology experience ideally including Prostate Cancer and Lung Cancer • Proficient in ICH-GCP and local regulatory requirements • Proficient with CTMS and eTMF clinical systems • Willing and able to travel up to 50% for on-site monitoring visits across the northeast region • Preference for candidates residing in Cincinnati, OH near major HUB airports

🏖️ Benefits

• Competitive base salary and 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

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