Clinical Research Associate (m/f/d) in Nijmegen 

About us 

Founded in 2004, GCP-Service is a privately owned Contract Research Organization (CRO) specializing in the management of clinical trials. 

We provide comprehensive clinical research services that help our clients bring innovative pharmaceuticals, medical devices, and in vitro diagnostics to market efficiently while maintaining the highest standards of quality and regulatory compliance. 

Tasks 

• Support, train, and guide investigational sites in the conduct of clinical trials 
• Ensure clinical studies are conducted in compliance with study protocols, SOPs, ICH-GCP guidelines, and all applicable regulatory requirements 
• Perform on-site and remote monitoring visits, including review of study documentation, source data, and patient records 
• Prepare monitoring reports and proactively identify, document, and follow up on protocol deviations and other compliance issues 
• Act as the primary point of contact for assigned study sites, providing ongoing support throughout the study lifecycle 

Qualification profile  

• At least 2 years of experience as a Clinical Research Associate (CRA) 
• Solid knowledge of ICH-GCP and applicable clinical research regulations 
• Fluent in Dutch, English and French, written and spoken 
• Excellent communication, interpersonal, and presentation skills
• Strong organizational skills with the ability to work independently and manage multiple priorities 
• Confident in learning and working with modern software applications 
• A collaborative, detail-oriented, and solution-focused mindset 
• Willingness to travel up to 50% within Netherland and Belgium and occasionally across Europe 

What We Offer 

• Flexible workplace: Home office or an office-based position in Nijmegen 
• Part-time employment: 3 days a week 
• Work-life balance: Flexible working hours, self-organized work, and 30 days of annual leave (for full time employment – adjusted proportionally to FTE)
• Competitive compensation: Attractive salary with long-term career development opportunities 
• Additional benefits: company mobile phone, modern work equipment, travel reimbursement (business and commuting), home work compensation, and company pension scheme 
• Professional development: Individual training opportunities and continuous professional development 

Our culture: A respectful, open, and collaborative working environment with short decision-making paths, mutual trust, and a strong commitment to quality 

We are looking for an experienced Clinical Research Associate who enjoys working independently, takes ownership, and is passionate about advancing clinical research. 

If you would like to contribute to the development of innovative medicines, medical devices, and in vitro diagnostics while working in a supportive and flexible environment, we would be delighted to hear from you.