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Clinical Research Associate (Site Director) - Argentina

coderabio

Nuevo
Senior 🇬🇧 English
CTMS eTMF

Descripcion del puesto

About the role

Codera, a Tang Capital company providing end-to-end drug development services for its portfolio companies, is hiring a Site Director, Clinical Operations for Argentina. The role manages clinical sites across the full study lifecycle, from site identification and start-up through monitoring, close-out and inspection readiness, ensuring patient safety, data quality and regulatory compliance.

Key responsibilities

  • Manage and monitor Phase I-IV studies at assigned sites, acting as the main point of contact from start-up to close-out
  • Carry out site monitoring, source data verification and remote data review and query resolution in line with ICH-GCP, SOPs, protocols and local regulations
  • Complete feasibility and site identification, prepare documents for regulatory and IRB/EC submissions, and negotiate site budgets and contracts
  • Develop site-specific recruitment, retention and follow-up plans, and support site audits and inspections
  • Resolve site performance and quality issues promptly, share best practices, coach colleagues and help improve Codera's systems and procedures

Required profile

  • Bachelor's degree in a life science discipline; nursing or RN is a plus
  • At least 3 years of direct site monitoring experience
  • Advanced English or professional working proficiency in English
  • Understanding of drug development, FDA, ICH and GCP guidelines and local regulations
  • Willingness to travel frequently (50-65%); candidates based in Argentina are preferred, with proximity to a major airport and flexibility for multi-day travel

Required skills

  • Detailed understanding of clinical site monitoring and study-level metrics
  • Preferred: experience with CTMS and eTMF systems
  • Excellent written and verbal communication, critical thinking and teamwork skills

What we offer

  • Discretionary bonuses and incentive programs may apply
  • Benefits package including employer-sponsored medical, dental and vision insurance, generous paid time off, retirement plan options and wellness and professional development programs

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Publicado hace 22 horas

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