Clinical Research Associate II role at a general CRO supporting clinical trials across Argentina. The position involves site qualification, monitoring, compliance oversight, and data quality assurance throughout the trial lifecycle, with approximately 6-10 days of monthly travel to investigative sites.
Responsibilities
Conduct site qualification, initiation, monitoring, and close-out visits per protocol and GCP requirements
Monitor study conduct, source documentation, informed consent, and case report forms for data quality and patient safety
Train site staff on protocol requirements and address compliance or study-related issues
Maintain regulatory documentation in Investigator Site File and Trial Master File
Partner with sites to resolve queries, manage safety reporting, and ensure timely data submission
Requirements
MD, PharmD, MSPH, PhD,



or equivalent medical/pharmacy degree with ≥1 year CRA Level I experience
Four-year degree in medical, biological, or health sciences with ≥2 years clinical research experience
Two-year college degree (preferably nursing or life sciences) with ≥2 years CRA Level I experience
Strong knowledge of GCP, ICH Guidelines, FDA/EU regulations, and applicable SOPs
Proficiency in Microsoft Office, IxRS, and electronic data capture systems
Fluency in English and local languages; valid passport and driving licence
Clinical research knowledge across multiple therapeutic areas or in-depth knowledge of 2-3 areas

📌 Clinical Research Associate Ii - Argentina (Buenos Aires)
🏢 Worldwide Clinical Trials
📍 Buenos Aires