Key Skills

Job Description

CRA II, Netherlands, Groningen, Hybrid or Remote. ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. 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. What ICON Can Offer You Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Core Responsibilities

The CRA II is responsible for managing investigative sites to ensure protocol compliance, patient safety, and data integrity. This includes conducting onsite and remote monitoring visits and maintaining inspection readiness for the TMF and ISF.

Requirements

Candidates must hold a bachelor's degree in a scientific or healthcare discipline and have previous monitoring experience within a CRO or pharmaceutical environment. Proficiency in ICH-GCP and fluent English communication skills are required.

Benefits

• Annual Leave
• Health Insurance
• Retirement Planning
• Employee Assistance Programme
• Life Assurance
• Childcare Vouchers
• Bike Purchase Schemes
• Discounted Gym Memberships
• Subsidized Travel Passes
• Health Assessments