Senior Clinical Research Associate

🔥 0 minutes ago

⛰️ Colorado – Remote

⛰️ Colorado – Remote

💵 $110.5k - $138.2k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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ICON plc

WebsiteLinkedInAll Job Openings

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

• Perform investigative site management and monitoring activities throughout the clinical trial lifecycle • Support the client's Oncology clinical trials to ensure data integrity, subject safety, and inspection readiness • Perform site management activities and maintain continuous inspection readiness • Act as the primary contact between the client's clinical trial team and sites • Perform remote and on-site monitoring/co-monitoring visits, including qualification, initiation, interim monitoring, and close-out visits • Perform oversight activities to assess monitoring quality and train or mentor less experienced CRAs • Document monitoring activities and submit or approve visit reports • Manage site essential document collection and TMF reconciliation with site files • Support local IRB/Ethics Committee submissions and confirm approvals • Review site Key Risk Indicator metrics, issues, and action items to detect trends and ensure prompt resolution • Determine root causes and develop or implement site CAPA plans • Deliver training on protocols, SOPs, GCPs, and regulations • Support sites and the client during regulatory inspections • Contribute to site identification, feasibility, qualification, and activation activities • Lead site engagement initiatives and foster relationships with key Oncology sites and networks

🎯 Requirements

• Bachelor's degree; scientific field preferred • 5+ years monitoring clinical trials and independently conducting on-site and remote monitoring visits • At least 2 years monitoring solid tumor clinical trials • 1+ years of early development oncology trial experience and/or Phase III Oncology trial experience • Solid tumor clinical trial experience required • Experience utilizing Veeva systems highly preferred • Demonstrated experience developing and maintaining site relationships and securing compliance • Expertise in GxPs and Oncology monitoring techniques, including Risk-Based Monitoring, and terminology • Experience collaborating with sites from initial engagement through close-out phases • Experience activating sites • Experience training site staff • Experience supporting sites and/or sponsors in regulatory inspections • Experience working within a Functional Services or in-house monitoring model preferred • Willingness to travel up to 50% • Legal right to work in the country where the role is based

🏖️ Benefits

• Competitive base salary • 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