Descrição da vaga
Hello there!
We are seeking an experienced Clinical Research Associate II (CRA II) based in Brazil to support and oversee clinical trial activities across oncology studies and additional therapeutic areas. The ideal candidate will bring 10+ years of CRA experience, including strong exposure to all phases of clinical trials (Phase I–IV) within a CRO environment
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This role requires a highly motivated professional with excellent site management capabilities, deep understanding of ICH-GCP guidelines, and strong communication skills in both English Spanish
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Key Responsibilities
- Conduct and oversee all clinical monitoring activities across Phase I–IV oncology and multi-therapeutic clinical trials in compliance with ICH-GCP, ANVISA regulations, protocol requirements, and sponsor
- SOPs.Independently manage investigative sites from start-up through close-out, ensuring data integrity, patient safety, and regulatory compli
- ance.Execute on-site and remote monitoring visits, including SDV, risk assessment, CAPA follow-up, IP accountability, and TMF/ISF re
- view.Drive site performance through proactive oversight of enrollment, protocol adherence, query management, and quality met
- rics.Identify, assess, and escalate operational risks, protocol deviations, and compliance issues, implementing mitigation strategies when requ
- ired.Maintain effective collaboration with sponsors, investigators, CRO stakeholders, and cross-functional teams to ensure study deliverables and timelines are achi
- eved.Support audit and inspection readiness activities, ensuring continuous compliance with global regulatory stand
- ards.Contribute to study execution across oncology and additional therapeutic areas within regional and global clinical prog
- rams.Provide operational support and mentorship to junior CRAs and site personnel as ne
- eded.Ensure accurate and timely completion of monitoring reports, follow-up letters, and clinical trial documentation within corporate KPIs and quality stand
ards.