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5 дней назад

CRA 2 - IQVIA Biotech - Czech Republic (Clinical Research)

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
CR
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
CRA 2 - IQVIA Biotech - Czech Republic (Clinical Research): Performing clinical site monitoring and management for studies in accordance with protocols, GCP, ICH guidelines, and regulatory requirements with an accent on site oversight, recruitment tracking, and study documentation. Focus on evaluating site quality, managing regulatory and enrollment progress, resolving data queries, and maintaining TMF and ISF records.

Location: Prague, Czech Republic

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 according to the study scope, GCP, ICH guidelines, and regulatory requirements.
  • Support site recruitment plans, track enrollment, and manage ongoing study expectations and issues.
  • Deliver protocol and study training and maintain regular communication with assigned sites.
  • Evaluate site practices, protocol adherence, data quality, and regulatory compliance, escalating quality issues when needed.
  • Track regulatory submissions, approvals, CRF completion, data queries, and study progress.
  • Maintain monitoring reports, follow-up letters, TMF documentation, and ISF compliance records.

Requirements

  • Bachelor's degree in a scientific or healthcare discipline, or an equivalent combination of education, training, and experience.
  • At least one year of on-site clinical study monitoring experience.
  • Knowledge of clinical research regulations, including GCP and ICH guidelines.
  • Good therapeutic and protocol knowledge, organizational ability, and problem-solving skills.
  • Good written and verbal Czech and English language skills are required.
  • Proficiency with Microsoft Word, Excel, PowerPoint, laptops, and applicable mobile devices.

Culture & Benefits

  • Full-time employment within a global clinical research and healthcare intelligence organization.
  • Collaboration with study teams, sites, investigators, clients, managers, and coworkers.
  • Responsibilities may include site financial management and invoice retrieval according to local requirements.

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