Senior Clinical Research Associate

November 4

🌾 Nebraska – Remote

Although this job is listed in Nebraska, this company may be open to hiring remote in other states.

🚗 Michigan – Remote

Although this job is listed in Michigan, this company may be open to hiring remote in other states.

+2 more states

🌾 Nebraska – Remote 🚗 Michigan – Remote 🏰 Missouri – Remote 🧀 Wisconsin – Remote

⏰ Full Time

🟠 Senior

🔬 Research Analyst

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ICON plc

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Pharmaceuticals • Biotechnology • Healthcare Insurance

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.

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

📋 Description

• Perform site management activities to support Oncology site success and maintain a continuous state of inspection readiness • Act as the primary contact and facilitate efficient communications between the clinical trial team and the sites • Perform remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in trials • May perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs • Promptly document monitoring activities and submit/approve visit reports • Manage site essential document collection and TMF reconciliation with site files • Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals • Regularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolution • Independently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans • Deliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations • Support sites during regulatory inspections • Contribute to site identification; drive site feasibility and qualification progress; and support site 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 Oncology trials independently conducting on-site and remote monitoring visits • 1+ years early development trial experience preferred • Solid tumor clinical trial experience is preferred • Experience utilizing Veeva CTMS for report writing is required • Demonstrated experience developing/maintaining site relationships and securing compliance • Expertise in GCPs 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 an FSP (or in-house) monitoring model is preferred • Willing to travel up to 50% domestically • Reside in Midwest Region USA

🏖️ 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.