Clinical Research Associate - Biotech

Clinical Research Associate (CRA II) – Oncology

📍 São Paulo

🕒 Full-time | ✈️ Travel required

The Role

We are seeking a Clinical Research Associate (CRA II) with at least 1 year of on-site monitoring experience in oncology to support the successful delivery of clinical trials. In this role, you will be responsible for site monitoring, compliance, and data quality, playing a critical role in bringing innovative therapies to patients.

You will work closely with investigative sites and cross-functional project teams to ensure studies are conducted in accordance with GCP, ICH guidelines, regulatory requirements, and study protocols.

Key Responsibilities

• Perform site selection, initiation, monitoring, and close-out visits in line with the contracted scope of work
• Ensure compliance with GCP, ICH, regulatory requirements, and study protocols
• Partner with site staff to support and track patient recruitment and enrollment strategies
• Deliver protocol and study-specific training to site personnel
• Assess site performance, identify quality risks, and escalate issues proactively
• Monitor study progress, including regulatory documentation, enrollment, CRF completion, and query resolution
• Ensure accurate and complete maintenance of TMF and ISF documentation
• Document monitoring activities through detailed visit reports, follow-ups, and correspondence
• Collaborate with cross-functional teams to support overall study execution and timelines
• Where applicable, support site-level recruitment planning and financial activities, including invoice tracking

Qualifications

• Bachelor’s degree in Life Sciences or a health-related field (or equivalent experience)
• Minimum 1 year of on-site monitoring experience, preferably in oncology
• Strong working knowledge of GCP, ICH guidelines, and regulatory requirements
• Excellent communication, organisation, and stakeholder management skills
• Ability and willingness to travel as required

Why apply?

• Work on oncology-focused clinical trials with meaningful patient impact
• Join a biotech-focused CRO environment known for agility and scientific alignment
• Gain exposure to high-quality studies and collaborative project teams
• Continue developing your CRA career within complex and innovative trials