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

GCP-Service International Ltd. & Co.KG; Nijmegen; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Home office option

Office-based position in Nijmegen

Travel reimbursement

Company pension scheme

30 days annual leave

Job summary

GCP-Service is seeking a Clinical Research Associate (m/f/d) to join our Nijmegen team. The role involves supporting clinical sites, ensuring regulatory compliance, and conducting on-site and remote monitoring visits across Europe.

The successful candidate will bring at least two years of CRA experience, fluency in Dutch, English, and French, and strong organizational and communication skills. Travel up to 50% will be required, with opportunities for professional development and a supportive,

Qualifications

• 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.
• Collaborative, detail-oriented, and solution-focused mindset.
• Willingness to travel up to 50% within Netherlands and Belgium and occasionally across Europe.

Responsibilities

• Support, train, and guide investigative 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.

Skills

ICH-GCP knowledge

Dutch language

English language

French language

Monitoring skills

Communication skills

Travel readiness

Tools

Clinical trial software

Job description

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

Aboutus

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 guideinvestigationalsitesin theconductofclinicaltrials
• Ensureclinicalstudiesareconductedincompliancewithstudyprotocols, SOPs, ICH-GCPguidelines, and allapplicableregulatoryrequirements
• Perform on-site and remotemonitoringvisits,includingreview ofstudydocumentation, sourcedata, andpatientrecords
• Preparemonitoringreportsandproactivelyidentify,document, and followuponprotocoldeviationsandothercomplianceissues
• Act as the primary point of contact for assigned study sites, providing ongoing support throughout the study lifecycle

Qualificationprofile

• At least2yearsofexperienceas a Clinical Research Associate (CRA)
• Solidknowledgeof ICH-GCP andapplicableclinicalresearchregulations
• Fluent inDutch,Englishand French,writtenand spoken
• Excellent communication, interpersonal, and presentation skills
• Strong organizationalskillswiththeabilitytoworkindependentlyand manage multiplepriorities
• Confidentinlearningandworkingwithmodernsoftwareapplications
• Acollaborative, detail-oriented, andsolution-focusedmindset
• Willingness to travel up to 50% within Netherland and Belgium and occasionally across Europe

WhatWeOffer

• Flexibleworkplace:Home officeoranoffice-basedpositioninNijmegen
• Part-timeemployment:3daysaweek
• Work-lifebalance:Flexibleworkinghours,self-organizedwork, and 30daysof annualleave(forfulltimeemployment–adjustedproportionallyto FTE)
• Competitivecompensation:Attractivesalarywithlong-termcareerdevelopmentopportunities
• 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.