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Clinical Research Associate (CRA) – Level 2

iqvia · Buenos Aires

New
Onsite Junior 🇬🇧 English
Good Clinical Practice (GCP) ICH guidelines regulatory requirements

Job description

About the role

IQVIA Biotech is seeking a Clinical Research Associate (CRA) Level 2 to support on‑site monitoring of clinical trials in oncology, cardiovascular or internal medicine. The role ensures compliance with protocols, regulatory standards and sponsor expectations.

Key responsibilities

  • Conduct site visits—including selection, initiation, monitoring, and close‑out—following GCP and ICH guidelines.
  • Collaborate with site staff on subject recruitment strategies and track enrollment progress.
  • Provide protocol‑specific training to site personnel and maintain ongoing communication.
  • Assess site performance, document findings, and escalate quality concerns as needed.
  • Maintain essential documents in the Trial Master File (TMF) and Investigator Site File (ISF) according to regulatory standards.

Required profile

  • Bachelor’s degree in life sciences or a related health field, or equivalent experience.
  • Minimum of 1 year of on‑site monitoring experience.
  • Ability to travel as required by project needs.

Required skills

  • Strong understanding of Good Clinical Practice (GCP).
  • Familiarity with ICH guidelines and regulatory requirements.
  • Experience with site management activities and documentation.

Questions fréquentes

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Source : ats:workday

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Published 6 hours ago

Expires 1 month from now

3 views · 0 interested

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iqvia

Buenos Aires