4 дня назад
Senior Clinical Research Associate (Brazil)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Research Associate (Brazil) (Clinical Research): Managing complex clinical trial sites and conducting on-site and remote monitoring across Brazil with an accent on patient safety, data integrity, regulatory compliance, and site start-up. Focus on identifying site risks, resolving protocol and data issues, maintaining audit readiness, and mentoring junior CRAs.
Location: Remote, Brazil; travel required, including up to 60% overnight travel on average and international travel as needed.
Company
provides clinical research and biopharmaceutical services supporting studies across Latin America.
What you will do
- Manage clinical trial sites independently, protecting patient safety and ensuring high-quality, reliable data.
- Conduct qualification, initiation, routine monitoring, close-out, oversight, on-site, and remote visits according to protocols, local laws, ICH-GCP, and SOPs.
- Lead site start-up activities, including feasibility, investigator recruitment, regulatory submissions, informed consent documentation, and study document preparation.
- Maintain trial management systems, monitoring reports, Investigator Site Files, Trial Master File reconciliation, and action tracking.
- Identify and resolve site risks, protocol deviations, data discrepancies, serious adverse events, and investigational product issues.
- Support Clinical Trial Managers and Project Managers, attend investigator and project meetings, and train and mentor junior CRAs.
Requirements
- Four-year college degree or equivalent experience in a scientific or healthcare discipline.
- At least 5 years of CRA experience in a CRO, pharmaceutical, biotechnology, or equivalent clinical research environment.
- Significant clinical trial site management experience.
- Professional-level English proficiency required.
- Working knowledge of clinical trial methodology, protocols, indications, GCP, ICH guidelines, and clinical monitoring procedures.
- Ability to work independently, prioritize workloads, resolve project issues, and communicate with sites, clients, and project teams.
Nice to have
- Graduate or postgraduate degree.
- Experience in rare or complex therapeutic areas, biopharma, oncology, or early-phase studies.
- Experience with EDC trials, EHR records, site start-up, feasibility, contract negotiations, and regulatory submissions in Brazil.
- Experience preparing formal presentations and study-specific training materials.
- Demonstrated focus on continuous improvement and process efficiency.
Culture & Benefits
- Remote work arrangement based in Brazil.
- Collaboration with global clinical monitoring, project, sponsor, investigator, and site teams.
- Opportunities to train and mentor new employees and junior monitors.
- Travel and participation in investigator meetings, sponsor meetings, and clinical training sessions according to project needs.
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