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4 дня назад

Senior Clinical Research Associate (Brazil)

Формат работы
remote (только Brazil)
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Brazil
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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

hirify.global 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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