Senior Clinical Research Associate (Pharmaceuticals)

TL;DR

Senior Clinical Research Associate (Pharmaceuticals): Performing clinical monitoring for assigned protocols and investigational sites with an accent on GCP compliance and regulatory requirements. Focus on conducting site initiation, interim, and close-out visits, and managing study-specific documentation.

Location: Must be based in the Netherlands and cover both the Netherlands and Belgium.

Company

hirify.global provides end-to-end consulting solutions to biotech, med device, and pharmaceutical organizations to accelerate drug and device programs.

What you will do

• Conduct all types of monitoring visits (initiation, interim, close-out) both in person and remotely.
• Ensure studies are documented in accordance with protocols, SOPs, and GCP.
• Perform study start-up activities, including site identification and Ethics Committee submissions.
• Review source documents and case report forms for data accuracy and integrity.
• Manage investigational supplies, including dispensing and reconciliation.
• Collaborate with investigators, site personnel, and cross-functional teams.

Requirements

• Over 5 years of experience as a Clinical Research Associate.
• Bachelor's degree or equivalent education/experience.
• Proficiency in EDC, CTMS, IVRS, and eTMF.
• Deep knowledge of ICH Guidelines, GCP, and local regulatory requirements.
• Excellent communication and interpersonal skills.
• Must be able to cover both the Netherlands and Belgium.

Culture & Benefits

• Freelance/B2B engagement.
• Flexible remote working options combined with in-person collaboration.
• Opportunity to work with a global leader in regulatory sciences and clinical research.
• Inclusive workplace committed to diversity, equity, and inclusion.