Clinical Research Associate 2 - Oncology Monitoring

About the role

IQVIA Biotech, a full-service CRO serving biotech sponsors, is hiring a Clinical Research Associate (CRA) in São Paulo. The role monitors and manages clinical sites so that studies comply with protocols, regulatory requirements and sponsor expectations, contributing to the integrity and quality of clinical research data. The position requires at least 1 year of on-site monitoring experience.

Key responsibilities

• Carry out site selection, initiation, monitoring and close-out visits in line with 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 to protect compliance and data integrity.
• Track 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) according to regulatory standards.
• Document site management activities, visit outcomes and follow-up actions in reports and correspondence.
• Collaborate 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.