CRA II

As a Clinical Research Associate, based in the Netherlands you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Key responsibilities:

Perform site qualification, site initiation, and closeout visits, ensuring regulatory and protocol compliance. Visits may be on-site or remote.
Generate queries and manage resolutions with site personnel.
Document activities via confirmation letters, follow-up letters, trip reports, communication logs and other required study documents as per SOPs and Study Monitoring Plan.
Perform investigational product accountability as per the protocol and Study Monitoring Plan.
Ensure to set up proper recruitment/maintenance plan based on appropriate analysis of capability of sites selected.
Act as primary liaison with site personnel.
Management and collection of site's study regulatory documents.
Enter data into tracking systems as required.
Assist and support audit preparation and CAPA implementation.
AE/SAE and expedited reporting and management.
AE/SAE and expedited reporting and management.

Requirements

• Degree in life sciences, pharmacy preferred.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Proven experience in on-site monitoring of clinical studies is a must
• Demonstrated proficiency in problem solving, juggling multiple priorities and a commitment to quality and customer focus.
• Proven ability to work independently in a fast-paced environment.
• Strong communication, interpersonal, and organizational skills.
• Must demonstrate good computer skills.
• Fluently Dutch and English

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.

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.

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