Senior Clinical Research Associate

🔥 13 hours ago

🐊 Florida, New York, +2 more states – Remote

🐊 Florida – Remote 🗽 New York – Remote 🌲 North Carolina – Remote 🔔 Pennsylvania – 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 to ensure sponsor and investigator obligations are met and comply with local regulatory requirements and ICH GCP guidelines • Assess potential investigative sites, initiate trials, instruct site personnel, and close trials at investigative sites • Perform 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 collected onsite or remotely • Provide regular site status information and update trial management tools • Complete monitoring activity documents according to sponsor SOPs • Work with clinical team members to resolve trial and clinical issues • Escalate site and trial issues according to sponsor SOPs • Perform essential document site file reconciliation • Perform source document verification and query resolution • 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 update tracking systems • Ensure required training is completed and documented • Function with little oversight at the senior level • Serve as a subject matter expert for clinical operations monitoring activities • Provide leadership to assigned clinical operations projects • Serve as observation and performance visit leader • Interact with other functional areas to resolve site issues and facilitate trial timelines

🎯 Requirements

• An undergraduate degree or its equivalent in clinical, science, or health related field from an accredited institution; a licensed health care professional (i.e. registered nurse) or equivalent work experience required • 2-5 years clinical monitoring experience required (CRA 2 for sponsor) • 5+ years clinical monitoring experience required (Sr CRA for sponsor) • Knowledge of ICH and local regulatory authority regulations regarding drug • Read, write and speak fluent English • Oncology monitoring II/III experience required • Experience doing feasibility/site selection/site start up required • Budget negotiations experience preferred • Legally authorized to work in the United States and must not require now or in the future sponsorship for employment visa status • Employment with ICON is contingent upon having the legal right to work in the country where the role is based

🏖️ 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