Clinical Research Associate: Trial Integrity & Site Coordination

Biopark

Louvain-la-Neuve

Remote

EUR 50,000 - 65,000

Full time

5 days ago
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Job summary

Biopark is seeking a Clinical Research Associate (CRA) Inteliphage to support the conduct of clinical trials, ensuring protocol compliance and data integrity. You will monitor sites, coordinate with investigators and internal teams, and help translate scientific work into reliable patient solutions.

The role combines scientific rigor with project coordination, covering site initiation, monitoring visits, data verification, and maintenance of trial master files, while upholding ICH-GCP and

Qualifications

  • Master’s degree in life sciences, pharmacy, biotechnology, clinical research, or a related field.
  • Experience in clinical research, ideally with interventional or observational studies.
  • Strong knowledge of ICH-GCP standards, regulatory requirements, and clinical trial processes.
  • Experience in clinical monitoring, site management, or study coordination.
  • Excellent organizational skills, rigor, and ability to manage priorities.
  • Strong autonomy, with ability to work in a team and interact with stakeholders.
  • Excellent written and verbal communication skills.

Responsibilities

  • Monitoring, coordinating, and following up on clinical trials in accordance with study protocols.
  • Ensuring compliance with ICH-GCP standards, internal procedures, and applicable regulatory requirements.
  • Preparing and conducting site selection, initiation, monitoring, and close-out visits.
  • Managing relationships with investigators, clinical site teams, and involved partners.
  • Verifying the quality, consistency, and accuracy of collected data.
  • Identifying, documenting, and following up on deviations, observations, or required corrective actions.
  • Writing monitoring reports and ensuring rigorous follow-up of ongoing actions.
  • Contributing to study-related documentation and trial master file activities.
  • Collaborating with internal teams, including clinical operations, quality, regulatory affairs, data management, and operations.

Skills

Clinical monitoring
Site management
Regulatory compliance
Data quality
ICH-GCP
Stakeholder communication
Documentation

Education

Master’s degree in life sciences or related field

Job description

Biopark is seeking a Clinical Research Associate (CRA) Inteliphage to support the conduct of clinical trials, ensuring protocol compliance and data integrity. You will monitor sites, coordinate with investigators and internal teams, and help translate scientific work into reliable patient solutions.

The role combines scientific rigor with project coordination, covering site initiation, monitoring visits, data verification, and maintenance of trial master files, while upholding ICH-GCP and

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