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9 дней назад

Clinical Research Associate, Multisponsor Team

Формат работы
hybrid
Тип работы
fulltime
Грейд
junior
Английский
b2
Страна
Romania
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Мэтч & Сопровод

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Описание вакансии

Текст:
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TL;DR
Clinical Research Associate, Multisponsor Team (Clinical Research): Performing site selection, initiation, monitoring, and close-out visits for multisponsor clinical studies with an accent on ICH-GCP compliance, patient recruitment, and study documentation. Focus on RCA and CAPA management, eTMF archiving, visit reporting, and collaboration with project teams across Romanian sites.

Location: Bucharest, Romania; hybrid model with office-based and home-based options. Romania-based candidates must be available to travel across the country.

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

  • Perform site selection, initiation, monitoring, and close-out visits in accordance with ICH-GCP guidelines.
  • Support clinical sites with patient recruitment activities.
  • Manage root cause analysis and corrective and preventive actions.
  • Report visit outcomes and study progress.
  • Maintain and archive study documents in the electronic trial master file.
  • Collaborate with project and study teams and prepare monitoring visit reports and follow-up letters.

Requirements

  • BSc or MSc degree, preferably in health sciences.
  • Based in Romania and proficient in Romanian and English.
  • Good knowledge and practical application of ICH-GCP.
  • At least one year of experience as a Clinical Research Associate.
  • Experience with CTMS, eTMF, and EDC systems, as well as different studies, phases, visit types, and therapeutic indications.
  • Driving license and availability to travel across Romania.

Culture & Benefits

  • Work on international clinical research projects with major global sponsors.
  • Stable workload with a focus on quality rather than quantity.
  • Exposure to innovative medicines and the drug development process.
  • Career development opportunities within the organization.
  • Flexible working conditions and an attractive remuneration package.

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