Clinical Research Associate – Site Management
msd · ARG - Buenos Aires - Munro
Descripcion del puesto
About the role
Join a global healthcare leader as a Clinical Research Associate, responsible for performance and compliance of assigned protocols and sites in Argentina. You will act as the primary site contact, ensuring study conduct aligns with ICH/GCP, local regulations, and company standards.
Key responsibilities
- Develop and maintain strong site relationships throughout all trial phases.
- Perform site monitoring activities (remote and on‑site) in compliance with ICH‑GCP, SOPs, and local laws.
- Coordinate site start‑up, regulatory documentation, and ongoing study maintenance.
- Conduct site visits (validation, initiation, monitoring, close‑out) and produce accurate visit reports.
- Identify and resolve site performance or compliance issues, escalating as needed.
- Maintain study data in CTMS, eTMF and other systems.
- Contribute to site selection, validation, and expansion of the clinical research territory.
Required profile
- Minimum 2 years of direct site management (monitoring) experience in bio/pharma or CRO.
- Fluent in English (verbal and written) with strong communication skills.
- Bachelor’s degree with a strong emphasis in science or biology.
- Ability to work independently across multiple protocols and therapy areas.
Required skills
- Knowledge of ICH/GCP guidelines and local clinical research regulations.
- Experience with CTMS and electronic Trial Master File (eTMF) systems.
- Proficiency in Microsoft Office and various clinical IT applications on computers, tablets, and mobile devices.
- Good documentation practices and data/metric analysis capabilities.
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msd
ARG - Buenos Aires - Munro