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7 часов назад

Clinical Research Associate (Biotech)

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
Australia
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
Clinical Research Associate (Biotech): Managing and monitoring multi-country clinical trials in compliance with study protocols, ICH-GCP, ISO 14155, and applicable regulations with an accent on site management, data quality, patient safety, and investigational product accountability. Focus on conducting monitoring visits, supporting patient recruitment, ensuring accurate clinical data, and maintaining trial documentation.

Location: Australia

Company

hirify.global is an international, science-driven biotech contract research organization founded in Italy that provides clinical trial management and related scientific, regulatory, statistical, and pharmacovigilance services.

What you will do

  • Identify, assess, initiate, monitor, and close out investigational sites.
  • Conduct feasibility, pre-study, initiation, monitoring, and close-out visits.
  • Ensure compliance with protocols, SOPs, ICH-GCP, ISO 14155, and applicable regulations.
  • Perform source data verification, maintain data quality, and support accurate and complete trial documentation.
  • Monitor patient recruitment, support sites in meeting targets, and ensure appropriate reporting of adverse events and protocol deviations.
  • Manage investigational product accountability and collaborate with sponsors, project teams, and site staff while supporting audits and mentoring junior CRAs.

Requirements

  • Degree in a scientific field.
  • At least 2 years of CRA or clinical trial monitoring experience.
  • Strong knowledge of ICH-GCP, ISO 14155, and clinical trial processes.
  • Good English and Microsoft Office skills.
  • Strong organizational, communication, and problem-solving skills.
  • Ability to work independently and collaboratively.

Culture & Benefits

  • Competitive salary with additional benefits and bonuses.
  • Opportunity for professional development within an expanding international company.
  • Work on multi-country clinical trials using specialized expertise, information technology solutions, and innovative approaches.

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