Description
We are seeking a Clinical Research Associate (CRA) to manage clinical studies in the Netherlands for small and medium-sized biotech sponsors across multiple therapeutic areas.
As a CRA, you will independently monitor Phase I-III clinical trials to ensure compliance with ICH-GCP and regulatory requirements. You will conduct site qualification, initiation, monitoring, and close-out visits, and manage study documentation, regulatory submissions, and ethics/IRB approvals.
Responsibilities:
- Manage clinical studies in the Netherlands for small and medium-sized biotech sponsors across multiple therapeutic areas
- Independently monitor Phase I-III clinical trials to ensure compliance with ICH-GCP and regulatory requirements
- Conduct site qualification, initiation, monitoring, and close-out visits
- Manage study documentation, regulatory submissions, and ethics/IRB approvals
- Collaborate with cross-functional teams and site staff to ensure high-quality data and patient safety
- Ensure study cost efficiency and timely issue resolution
Requirements:
- Life science degree or equivalent
- 2 years or more experience as a Clinical Research Associate, with an understanding of clinical trial processes and regulatory requirements within a CRO or Pharma environment
- Knowledge of clinical trial processes and regulatory standards
- Excellent communication, organization, and problem-solving skills
- Proficiency with clinical trial systems and tools
- Fluency in Dutch and English, both spoken and written
- Valid driver's license
Benefits:
- 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
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