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2 дня назад

CTA-Shanghai

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
China
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
CTA-Shanghai (Clinical Research Administration): Maintaining Trial Master File documentation, clinical study records, supplies, and data-flow tracking with an accent on document accuracy, regulatory compliance, and project timelines. Focus on reviewing study files, coordinating clinical communications, managing Case Report Forms and queries, and supporting CRA site-monitoring activities.

Location: Shanghai, China

Company

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

What you will do

  • Maintain clinical documents and systems, including the Trial Master File, to track site compliance and performance within project timelines.
  • Prepare, handle, distribute, file, and archive clinical documentation and reports according to standard operating procedures.
  • Review study files for completeness and support the tracking and management of Case Report Forms, queries, and clinical data flow.
  • Prepare and distribute Clinical Trial Supplies while maintaining accurate tracking information.
  • Act as a central contact for designated project communications, correspondence, and related documentation.
  • Accompany Clinical Research Associates on site visits after completing the required training.

Requirements

  • High school diploma or equivalent, or an equivalent combination of education, training, and experience.
  • Three years of administrative support experience.
  • Working knowledge of Microsoft Word, Excel, and PowerPoint.
  • Good written and verbal English communication skills are required.
  • Effective time management, organizational, and relationship-building skills.
  • Awareness of Good Clinical Practice and ICH guidelines, as well as applicable clinical trial protocol requirements.

Culture & Benefits

  • Full-time employment.
  • Work in collaboration with Clinical Research Associates and Regulatory and Start-Up teams.
  • Exposure to clinical research operations and regulatory documentation.

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