Назад
Company hidden
11 дней назад

Senior Clinical Research Associate (Chile) (Clinical Research)

Формат работы
remote (только Chile)
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Chile
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:
/
TL;DR
Senior Clinical Research Associate (Chile) (Clinical Research): Managing complex clinical trial sites across Chile, including study start-up, monitoring, regulatory submissions, patient safety, and data quality with an accent on ICH-GCP compliance, site management, and audit readiness. Focus on conducting site visits, resolving protocol and data issues, managing investigational product accountability, and mentoring junior CRAs.

Location: Remote, Chile. Up to 60% overnight travel on average may be required, with international travel as needed.

Company

hirify.global provides clinical research and biopharmaceutical development services.

What you will do

  • Manage clinical trial sites independently, protecting patient safety and maintaining data quality.
  • Lead study start-up activities, including feasibility, investigator recruitment, regulatory submissions, informed consent adaptations, and essential document collection.
  • Conduct qualification, initiation, routine monitoring, close-out, and monitoring oversight visits in accordance with protocols, local laws, ICH-GCP, and SOPs.
  • Maintain trial management systems, monitoring reports, Investigator Site Files, Trial Master File reconciliation, and risk/action tracking.
  • Review clinical data, resolve queries and discrepancies, monitor investigational product accountability, and process Serious Adverse Events.
  • Support Clinical Trial and Project Managers, investigator meetings, client presentations, protocol development, and mentoring of 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, or biotechnology organization, or equivalent relevant experience.
  • Significant clinical research or clinical trial site management experience.
  • Professional-level English proficiency required.
  • Working knowledge of clinical trial methodology, protocols, indications, GCP, and ICH guidelines.
  • Ability to work independently, prioritize workloads, resolve project issues, and communicate with investigators, clients, and study teams.

Nice to have

  • Graduate or postgraduate degree.
  • Experience in rare or complex therapeutic areas, biopharma, oncology, or early-phase studies.
  • Experience monitoring EDC trials and EHR records.
  • Country-specific site start-up experience, including feasibility, contract negotiations, and submissions.
  • Experience preparing formal presentations and improving clinical research processes.

Culture & Benefits

  • Remote work arrangement based in Chile.
  • Independent planning combined with collaboration across global clinical research and project teams.
  • Opportunities to train and mentor new employees and junior monitors.
  • Participation in clinical training sessions, investigator meetings, and sponsor-facing activities.
  • Travel-based work across assigned regional study sites, with international travel when required.

Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →