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Senior Clinical Research Associate – Argentina

Precision For Medicine · Buenos Aires

Nuevo
Senior 🇬🇧 English
ICH-GCP site management

Descripcion del puesto

About the role

We are expanding our clinical research capabilities across Latin America and are looking for a Senior Clinical Research Associate to lead complex studies in Argentina. The role combines study start‑up, on‑site monitoring and ongoing site management to ensure patient safety and high‑quality data.

Key responsibilities

  • Oversee all aspects of site management, from feasibility and investigator recruitment to EC/IRB submissions and regulatory documentation.
  • Conduct pre‑study, initiation, routine monitoring and close‑out visits in accordance with protocol, local laws, ICH‑GCP and company SOPs.
  • Prepare accurate monitoring reports, confirmation letters and other required documentation.
  • Support audit readiness, assist with budget negotiations and investigator contract execution.
  • Verify informed consent processes and assess safety or data‑integrity issues at each site.
  • Mentor junior CRA staff and provide guidance to Clinical Trial Managers or Project Managers.
  • Enter and track data in trial management systems to support recruitment, retention and reporting.

Required profile

  • Extensive experience managing complex clinical trials in a CRO or pharmaceutical environment.
  • Proven ability to work independently and support senior project leadership.
  • Experience training and mentoring junior staff members.
  • Strong understanding of local regulatory requirements in Argentina.

Required skills

  • ICH‑GCP knowledge
  • Clinical trial monitoring
  • Site management
  • Regulatory compliance
  • Budget negotiation

Questions fréquentes

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Publicado hace 2 semanas

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Precision For Medicine

Buenos Aires