Clinical Research I Monitoring

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 values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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.

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.

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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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• 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

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply