Clinical Research Associate

🔥 26 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 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

• Work on multiple trials across cross-therapeutic areas with a start-up focus • Collaborate with country operations teams to identify, select, and activate clinical trial sites according to timelines and requirements • Perform Site Qualification Visits to assess site eligibility • Build relationships with site personnel to facilitate onboarding • Ensure compliance with ICH-GCP guidelines, local regulatory standards, and internal SOPs • Coordinate collection of regulatory approvals, contracts, and essential documents for site activation • Act as the main point of contact for sites, study teams, and external stakeholders during start-up • Manage investigator contracts, regulatory documents, and site-specific start-up activities • Provide status updates on project milestones • Monitor, report, and analyze KPIs related to site selection and start-up timelines • Identify and address issues that may delay study initiation or affect trial deliverables • Maintain precise documentation for inspection readiness • Support sites through activation until “Green Light” status • Coordinate completion of pre-study requirements including contracts, budgets, and essential documentation • Assist with audit and inspection preparations

🎯 Requirements

• Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences • Preferred location is near a major airport • Must have 2 -3 years’ experience in monitoring pharmaceutical industry clinical trials • Have a minimum of 1-3 years' experience monitoring oncology clinical trials • Study Start up experience required • Analytical/risk-based monitoring experience is an asset • Ability to actively drive patient recruitment strategies at assigned sites • Ability to partner closely with investigator and site staff to meet study timelines • Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, dashboards/metrics, IWRS, safety reporting) • Strong communication and influencing skills to effectively manage study sites remotely and face to face • Strong team member and self-starter with the ability to work independently • In-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements • Legally authorized to work in the United States • Must not require, now or in the future, sponsorship for employment visa status

🏖️ 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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