Clinical Research Associate (CRA) - Biotech Argentina

About the role

IQVIA Biotech Argentina is hiring a Clinical Research Associate (CRA) to monitor and manage clinical sites so that clinical trials run successfully. The role ensures compliance with study protocols, regulatory requirements and sponsor expectations, and contributes to the integrity and quality of clinical research data. The position requires at least 1 year of on-site monitoring experience in oncology, cardiovascular or internal medicine.

Key responsibilities

• Carry out site visits (selection, initiation, monitoring and close-out) according to the contracted scope, GCP and ICH guidelines.
• Work with site staff to implement and track subject recruitment strategies aligned with project timelines and enrollment goals.
• Deliver protocol and study-specific training to site personnel and keep communication open to manage expectations and resolve issues.
• Assess site performance and adherence to the protocol, escalating quality concerns as needed.
• Monitor study progress by tracking regulatory submissions, subject enrollment, CRF completion and resolution of data queries.
• Ensure documents are kept in the Trial Master File (TMF) and Investigator Site File (ISF) in line with regulatory standards.
• Document site management activities, visit outcomes and follow-up actions in reports and correspondence.
• Work with cross-functional project teams; depending on the project, support recruitment planning and financial management, including invoice collection and budget tracking.

Required profile

• Bachelor's degree in life sciences or a health-related field, or equivalent experience.
• At least 1 year of on-site monitoring experience.
• Ability to travel as required by the project.

Required skills

• Strong understanding of GCP and ICH guidelines.
• Understanding of regulatory requirements.