Clinical Research Associate (Site Director) - Argentina
coderabio
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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