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Clinical Research Associate

Clinical Research Associate

Hlx Life SciencesMexico, Mexico
Hace 23 horas
Descripción del trabajo

🕒 Contract Length : Short-term (site close-out focused)

📅 Start Date : Immediate

💼 Engagement : Freelance / Independent Contractor

About the Role

We are supporting a global biotech running an oncology programme and are seeking a freelance CRA based in Mexico to support close-out activities at two clinical sites. This role is ideal for an experienced independent CRA who can step in quickly and ensure high-quality, compliant close-out execution.

Key Responsibilities

  • Conduct site close-out visits in line with ICH-GCP, SOPs and study-specific requirements
  • Ensure complete and accurate TMF / eTMF documentation ahead of study closure
  • Reconcile investigational product, essential documents, and outstanding queries
  • Verify proper reporting and resolution of AEs / SAEs before site closure
  • Collaborate with sponsor and internal teams to finalise all close-out documentation
  • Provide any required follow-up after the visits to ensure full inspection readiness

Requirements

  • Proven experience as a freelance or independent CRA
  • Experience performing site close-out activities
  • Strong understanding of GCP, ICH guidelines, and site management
  • Ability to work autonomously and manage tight timelines
  • Oncology experience helpful but not essential for this assignment
  • Full fluency in Spanish; professional English proficiency preferred
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    Research Associate • Mexico, Mexico

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