Senior Clinical Research Associate

🔥 0 minutes ago

🌽 Illinois, Nebraska, +2 more states – Remote

🌽 Illinois – Remote 🌾 Nebraska – Remote 🏰 Missouri – Remote 🧀 Wisconsin – 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

• Implement and monitor clinical trials for compliance with sponsor and investigator obligations, local regulations, and ICH GCP guidelines • Assess investigative site qualifications and initiate, conduct, and close clinical trials at sites • Conduct site startup activities, including regulatory document collection, informed consent review, IRB/IEC submission support, and budget and contract negotiations • Review and verify clinical trial data onsite or remotely • Provide site status updates and maintain trial management tools and tracking systems • Complete monitoring activity documentation according to sponsor SOPs • Collaborate with clinical team members to resolve trial and clinical issues • Escalate site- and trial-related issues until resolved or closed • Reconcile essential document site files, perform source document verification, and resolve queries • Assess investigational product accountability, dispensation, and compliance • Verify serious adverse event reporting according to trial specifications and ICH GCP guidelines • Communicate with investigative sites and ensure required training is completed and documented • Function with little oversight and potentially serve as a clinical operations monitoring subject matter expert • Lead assigned projects and support complex studies or sites

🎯 Requirements

• Undergraduate degree or equivalent in a clinical, science, or health-related field from an accredited institution, or equivalent work experience • Licensed health care professional, such as a registered nurse, or equivalent work experience • 5+ years of clinical monitoring experience required for Senior CRA level • Knowledge of ICH and local regulatory authority regulations regarding drugs • Fluent English reading, writing, and speaking skills • Oncology Phase II/III monitoring experience • Experience leading observation and performance visits • Experience with feasibility, site selection, and site startup • Legally authorized to work in the United States • Must not require now or in the future sponsorship for employment visa status • Budget negotiation experience preferred • Advanced negotiating skills may be required for assigned clinical tasks

🏖️ Benefits

• Competitive base salary and 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 • Reasonable accommodations during the recruitment process