CRA II / Senior CRA

Make it in the North; Groningen; Hybrid; EUR 52,000 - 70,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Global EAP LifeWorks

Life assurance

Flexible benefits

Job summary

ICON in Groningen, NL, seeks a Clinical Research Associate II to ensure patient safety, data integrity and regulatory compliance across trials. You will monitor sites, build strong stakeholder relationships and support regulatory submissions in a hybrid/remote role within the Netherlands.

Ideal candidates have CRO/pharma monitoring experience, a scientific degree, and fluency in English, with willingness to travel for onsite visits as required.

Qualifications

• Bachelor's degree in a scientific, healthcare or related discipline.
• Previous monitoring experience in CRO or pharma.
• Strong understanding of ICH-GCP and trial processes.
• Ability to independently manage investigative sites and monitoring activities.
• Excellent communication with sites, sponsors and stakeholders.
• Strong organisational skills with attention to detail.
• Experience with electronic systems and trial technology platforms.
• Fluent English (written and spoken).
• Willingness to travel for onsite monitoring.

Responsibilities

• Independently manage assigned investigative sites, ensuring protocol compliance, data quality and patient safety.
• Conduct onsite and remote monitoring visits in line with study requirements and risk-based monitoring.
• Verify informed consent processes, source documentation and adherence to study protocols.
• Maintain site essential documentation (ISF and TMF) for inspection readiness.
• Identify and address study risks, issues and data discrepancies.
• Build strong relationships with investigators, site staff and sponsor representatives.
• Train site staff and maintain ongoing communication throughout the study lifecycle.
• Contribute to regulatory submissions, audits and inspection readiness activities.
• Collaborate with Clinical Operations, PM and cross-functional teams to achieve milestones and recruitment goals.
• Ensure studies comply with ICH-GCP, protocols and sponsor SOPs.

Skills

Communication

Relationship-building

Organisational skills

Attention to detail

Travel readiness

Electronic systems

Education

Bachelor's degree in science/healthcare

Tools

EDC systems

Job description

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

• 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, elevate 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

• 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 escalated 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.