Clinical Research I Monitoring

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.

What You Will Do:

We are seeking an experienced Clinical Research Associate (CRA II) or Senior Clinical Research Associate (SCRA) to support the successful execution of global clinical trials, with a preference for oncology experience. This role offers the opportunity to contribute to the development of innovative therapies while ensuring the highest standards of clinical research quality, regulatory compliance, and patient safety.

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Key Responsibilities:

• 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.

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Your Profile:

• 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

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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