Clinical Research Associate I (CRA I) – São Paulo

About the role

Join our team as a Clinical Research Associate (CRA) to support and manage clinical trial sites throughout all phases of the study lifecycle, ensuring compliance, data quality, and patient safety.

Key responsibilities

• Serve as the primary contact for assigned research sites and build strong relationships with investigators and site staff.
• Conduct remote and on‑site monitoring activities in compliance with ICH‑GCP, local regulations, protocols, and company procedures.
• Perform site qualification, initiation, monitoring, and close‑out visits and maintain study and regulatory documentation.
• Support site activation, ensure data quality, protocol compliance, and participant safety, and escalate issues as needed.
• Maintain accurate records in clinical systems such as CTMS and eTMF and support audit, inspection, and co‑monitoring activities.

Required profile

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Biology, Biomedicine, or related discipline.
• Previous experience in clinical research, site coordination, clinical operations, or similar roles (e.g., CTA, Research Coordinator, Research Nurse).
• Fluent Portuguese and advanced English (written and spoken).
• Strong organizational, communication, and stakeholder‑management skills with ability to prioritize multiple tasks.

Required skills

• Knowledge of ICH‑GCP and clinical research processes.
• Experience with clinical systems such as CTMS, eTMF, and EDC.
• Proficiency in MS Office applications.