Clinical Research Associate

🔥 0 minutes ago

🇳🇱 Netherlands – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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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

• Conduct site monitoring visits, including pre-study, site initiation, routine monitoring, and closeout visits as required • Participate in co-monitoring visits when applicable • Ensure assigned study sites achieve key milestones, including study startup, patient recruitment, database lock activities, and study closeout • Complete monitoring visit reports accurately and within required timelines • Support investigator and site identification and feasibility activities • Assist sites with Institutional Review Board (IRB) and Ethics Committee (EC) submissions • Support clinical trial site contract and budget negotiations • Develop and implement site-specific patient recruitment strategies, monitoring progress and adapting plans to meet enrollment goals • Manage site communications, queries, and ongoing relationships throughout the study lifecycle • Deliver protocol and study-related training to assigned sites and maintain regular communication to address expectations, risks, and issues • Collaborate closely with Clinical Study Managers (CSMs) and cross-functional study teams • Evaluate site performance, protocol compliance, data quality, and adherence to ICH-GCP and applicable regulatory requirements, escalating quality concerns as appropriate • Track study progress, including regulatory submissions, approvals, subject enrollment, CRF completion, data query resolution, and overall site performance • Prepare and maintain essential study documentation, including monitoring reports, follow-up letters, action plans, and other required records • Promote study awareness and support site engagement to optimize study execution • Assist study sites and fellow CRAs in audit and inspection preparation, response activities, and resolution of quality findings • Perform quality control of Trial Master Files (TMFs), including setup, maintenance, reconciliation, and closeout activities, while supporting ancillary study services as needed

🎯 Requirements

• Bachelor's degree or higher in Life Sciences or another relevant scientific discipline • Minimum of 2.5 years of clinical monitoring experience for CRA II level, or 4+ years for Senior CRA level, within a pharmaceutical company, biotechnology company, or Contract Research Organization (CRO) • Strong understanding of clinical trial processes, ICH-GCP guidelines, and applicable regulatory requirements • Experience in global oncology clinical trials is preferred • Excellent communication, interpersonal, and stakeholder management skills • Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment • Fluent in written and spoken English and Dutch • 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