CRA II / Senior CRA - Early Phase

Clinical Research Associate II (CRA II)

At ICON, our people are at the centre of everything we do. As a Clinical Research Associate II, you will play a key role in ensuring patient safety, data integrity and regulatory compliance across clinical trials, while building strong relationships with investigative sites and study stakeholders.

Supporting ICON's Early Phase Clinical Research Centre in Groningen, one of Europe's largest Phase I/II research units, you'll contribute to the delivery of innovative early development studies in a state-of-the-art research environment. From first-in-human studies through proof-of-concept programmes, you'll gain exposure to some of the most advanced early phase research in the industry, working closely with clinical, laboratory and medical teams to support high-quality study execution.

This is a hybrid or Remote role based in the Netherlands. Candidates should be located within a reasonable commuting distance of Groningen and able to attend ICON's Early Phase Clinical Research Centre as required.

What You Will Do

Your focus will be on delivering high-quality monitoring activities, ensuring site performance and maintaining inspection readiness across your studies.

• Independently manage assigned investigative sites, ensuring protocol compliance, data quality and patient safety.
• Conduct onsite and remote monitoring visits in accordance with study requirements and risk-based monitoring strategies.
• Verify informed consent processes, source documentation and adherence to study protocols.
• Maintain site essential documentation, including ISF and TMF records, ensuring continuous inspection readiness.
• Identify, escalate and support resolution of study risks, issues and data discrepancies.
• Build strong relationships with investigators, site staff and sponsor representatives to drive study success.
• Support site staff through training, guidance and ongoing communication throughout the study lifecycle.
• Contribute to regulatory submissions, audit preparation and inspection readiness activities where required.
• Collaborate closely with Clinical Operations, Project Management and cross-functional study teams to achieve study milestones and recruitment goals.
• Ensure studies are conducted in accordance with ICH-GCP, protocol requirements, ICON and sponsor SOPs, and applicable regulatory requirements.

Your Profile

You will have strong clinical monitoring experience and the ability to work independently while managing competing priorities across multiple sites.

• Bachelor's degree in a scientific, healthcare or related discipline.
• Previous monitoring experience within a CRO, pharmaceutical company or clinical research environment.
• Strong understanding of ICH-GCP, clinical research regulations and clinical trial processes.
• Demonstrated ability to independently manage investigative sites and monitoring activities.
• Excellent communication and relationship-building skills with sites, sponsors and internal stakeholders.
• Strong organisational and prioritisation skills, with a high level of attention to detail.
• Experience working with electronic systems and clinical trial technology platforms.
• Ability to identify risks, propose solutions and escalate issues appropriately.
• Fluent English communication skills, both written and verbal.
• Willingness to travel as required for onsite monitoring visits and study activities.
   

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