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, is hiring a Site Director, Clinical Operations for Argentina. The role manages overall clinical site activity, from site identification and start-up through monitoring, close-out and inspection readiness, ensuring patient safety, rights and well-being and complete, accurate data. Candidates based in Argentina are preferred, and must be able to travel frequently (50-65%); relocation is not required.
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
- Complete feasibility and site identification, and prepare documents for regulatory and IRB/EC submissions
- Negotiate site budgets and contracts, and develop recruitment, retention and follow-up plans
- Support site audits and inspections, and escalate site performance or quality issues
- 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
- Bilingual in English and French
- Understanding of ICH-GCP, FDA and local regulations, and of drug development
- Willingness to travel 50-65%, with proximity to a major airport and flexibility for multi-day trips
Required skills
- Proficiency in CTMS and eTMF systems preferred
- Interpretation of study-level metrics and risk mitigation across the study lifecycle
- Excellent written and verbal communication and teamwork skills
What we offer
- Estimated annual base salary of $160,000-$210,000, with possible discretionary bonuses
- Medical, dental and vision insurance, generous paid time off, retirement options and wellness and professional development programs
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