Senior Clinical Research Associate

Senior Clinical Research Associate (CRA II) – Oncology

Santo André, São Paulo, Brazil

Industry: Clinical Research / CRO / Life Sciences

🧪 Work Setting: Site-based oncology clinical trial monitoring (multi-site, sponsor-led studies)

Overview

A global clinical research organisation is seeking a Senior Clinical Research Associate (CRA II) to support oncology clinical trials. The role focuses on independent site monitoring, protocol compliance, and ensuring high-quality clinical data across study sites.

Key Responsibilities

• Conduct full cycle site visits:
• Selection
• Initiation
• Monitoring
• Close-out
• Ensure compliance with GCP and ICH guidelines
• Support and track patient recruitment and enrolment strategies
• Deliver protocol training and maintain ongoing site communication
• Monitor study progress, including:
• Regulatory submissions and approvals
• CRF completion and data query resolution
• Maintain Trial Master File (TMF) and Investigator Site File (ISF) compliance
• Document monitoring findings, follow-ups, and site actions
• Identify and escalate protocol deviations or quality risks
• Collaborate with cross-functional clinical project teams
• Support recruitment planning and, where required, basic site budget/invoice tracking

Requirements

Education

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related healthcare field (or equivalent experience)

Experience

• Minimum 1 year of independent on-site CRA monitoring experience
• Strong experience in oncology clinical trials
• Experience conducting full-site monitoring visits (not remote-only roles)

Core Knowledge (Mandatory)

• Strong understanding of:
• Good Clinical Practice (GCP)
• ICH-GCP guidelines
• Clinical trial regulatory requirements
• Familiarity with:
• TMF (Trial Master File) management
• ISF (Investigator Site File) maintenance
• Clinical trial documentation standards

Skills & Competencies

• Ability to independently manage site monitoring activities
• Strong attention to compliance and data integrity
• Effective communication with investigators and site staff
• Experience tracking enrolment, CRFs, and data queries
• Strong documentation and reporting skills
• Willingness to travel frequently for site visits

Additional Notes

• Oncology-focused clinical trial environment
• Site-based monitoring role (not remote)
• Requires independent monitoring capability at CRA II level