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6 дней назад

Clinical Research Associate II

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
UK
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 II (Clinical Research): Conducting site monitoring and managing interventional clinical studies in line with GCP, ICH, and regulatory requirements with an accent on site oversight, subject recruitment, and study documentation. Focus on evaluating site quality, tracking study progress and regulatory submissions, maintaining TMF and ISF records, and resolving monitoring findings.

Location: Reading, Berkshire, United Kingdom; full UK right to work required

Company

IQVIA 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 for interventional clinical studies.
  • Drive and track subject recruitment plans and support study predictability.
  • Deliver protocol and study training while maintaining communication with assigned sites.
  • Evaluate site quality, protocol adherence, and compliance with applicable regulations, escalating issues when required.
  • Track regulatory submissions, approvals, recruitment, enrollment, CRF completion, and data query resolution.
  • Maintain TMF and ISF documentation, prepare monitoring reports, follow-up letters, and action plans, and collaborate with study teams.

Requirements

  • At least 2 years of on-site monitoring experience with interventional studies.
  • Degree in a scientific or healthcare discipline, or equivalent industry experience.
  • Strong knowledge of Good Clinical Practice and International Conference on Harmonization guidelines.
  • Ability to build effective working relationships with colleagues and clients.
  • Full UK right to work required; visa sponsorship is not available.

Culture & Benefits

  • Career development opportunities and access to the AI-powered Career Connections talent marketplace.
  • Mentorship opportunities through Employee Resource Groups.
  • Flexible working to support work-life balance and professional success.
  • Well-being support covering physical, mental, and financial health.

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