Clinical Research Associate II (CRA II) – São Paulo

About the role

We are seeking a motivated Clinical Research Associate II to serve as the primary site contact for clinical studies in São Paulo. You will ensure compliance with regulations and support the successful execution of our trials.

Key responsibilities

• Independently manage trial sites from initiation through close‑out, including SQV, SIV, routine monitoring and close‑out visits.
• Review source documents and study data to ensure quality, patient safety and protocol adherence.
• Identify, escalate and resolve site‑related issues and risks, preparing detailed monitoring visit reports.
• Maintain inspection‑ready records in CTMS, eTMF and other clinical systems.
• Build effective relationships with investigators, site personnel and cross‑functional teams.

Required profile

• Bachelor’s degree.
• Experience conducting on‑site monitoring visits at hospitals and research centers.
• Experience managing sites throughout the clinical trial lifecycle.
• Advanced English proficiency (written and spoken).
• Strong communication, organization and stakeholder management skills.

Required skills

• ICH‑GCP knowledge.
• Clinical trial processes and regulatory requirements.
• Use of CTMS and eTMF systems.
• Adverse Event Reporting System.
• Clinical Research Methods.