Description
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
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.
Responsibilities
- 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
- 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.
Rewards & 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