Descrição da vaga
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:SelectionInitiationMonitoringClose-outEnsure compliance with GCP and ICH guidelinesSupport and track patient recruitment and enrolment strategiesDeliver protocol training and maintain ongoing site communicationMonitor study progress, including:Regulatory submissions and approvalsCRF completion and data query resolutionMaintain Trial Master File (TMF) and Investigator Site File (ISF) complianceDocument monitoring findings, follow-ups, and site actionsIdentify and escalate protocol deviations or quality risksCollaborate with cross-functional clinical project teamsSupport recruitment planning and, where required, basic site budget/invoice trackingRequirements
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 experienceStrong experience in oncology clinical trialsExperience conducting full-site monitoring visits (not remote-only roles)Core Knowledge (Mandatory)
Strong understanding of:Good Clinical Practice (GCP)ICH-GCP guidelinesClinical trial regulatory requirementsFamiliarity with:TMF (Trial Master File) managementISF (Investigator Site File) maintenanceClinical trial documentation standardsSkills & Competencies
Ability to independently manage site monitoring activitiesStrong attention to compliance and data integrityEffective communication with investigators and site staffExperience tracking enrolment, CRFs, and data queriesStrong documentation and reporting skillsWillingness to travel frequently for site visitsAdditional Notes
Oncology-focused clinical trial environmentSite-based monitoring role (not remote)Requires independent monitoring capability at CRA II level