23 oct
|
Worldwide Clinical Trials
|
Buenos Aires
23 oct
Worldwide Clinical Trials
Buenos Aires
Worldwide Clinical Trials seeks a Clinical Research Associate to support site management activities across the clinical study lifecycle in Argentina and Brazil. The role involves coordinating with sites, managing documentation, reviewing data, and ensuring compliance with regulatory standards and study protocols. This is a remote position requiring trilingual proficiency in English, Spanish, and Portuguese.
Responsibilities
Support site management activities including feasibility, initiation, monitoring, and close-out throughout study lifecycle
Maintain communication with assigned sites and coordinate with Clinical Trial Managers and field CRAs
Review site documentation for quality and completeness; support TMF filing and ISF maintenance
Review EDC records for compliance and assist sites with resolving data and vendor queries
Coordinate study materials, track action items,
and ensure sites maintain required training and regulatory documentation
Requirements
Four-year degree in medical, biological, physical, health, pharmacy, or related science
Alternatively: two-year degree plus one year clinical research experience, or equivalent education plus two years experience
Knowledge of FDA/EU regulations, ICH Guidelines, and local regulatory requirements
Strong written and verbal communication skills in English, Spanish, and Portuguese
Proficiency with Microsoft Office, IVRS, and electronic CRF systems
Understanding of clinical research principles, GCP, and standard operating procedures
Planning, organization, and time-management skills
📌 In-House Clinical Research Associate I / Ii - Spanish / English / Portuguese (Argentina /Brazil) (Buenos Aires)
🏢 Worldwide Clinical Trials
📍 Buenos Aires