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5 дней назад

Senior Clinical Research Associate

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
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
Senior Clinical Research Associate (Clinical Research): Monitoring and managing clinical trial sites in accordance with study protocols, Good Clinical Practice, applicable regulations, and sponsor requirements with an accent on site oversight, recruitment tracking, and study documentation. Focus on evaluating site compliance, resolving data queries, maintaining trial records, and coordinating study execution with investigators and project teams.

Location: Prague, Czech Republic

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 line with the contracted scope and Good Clinical Practice.
  • Support site recruitment plans, track enrollment, and manage study progress and project expectations.
  • Deliver protocol and study training and maintain regular communication with assigned sites.
  • Evaluate site quality, protocol compliance, and adherence to applicable clinical research regulations, escalating issues when needed.
  • Track regulatory submissions, case report forms, data queries, and study documentation, including Trial Master File and Investigator's Site File records.
  • Prepare monitoring reports, follow-up letters, action plans, and other required study documentation while collaborating with study team members.

Requirements

  • Bachelor's degree in a scientific or healthcare discipline preferred; equivalent education, training, and experience may be accepted.
  • At least 2 years of on-site monitoring experience.
  • Knowledge of clinical research regulatory requirements, Good Clinical Practice, and International Conference on Harmonization guidelines.
  • Good therapeutic and protocol knowledge.
  • Proficiency with Microsoft Word, Excel, PowerPoint, and applicable laptop and mobile device tools.
  • Good command of English, along with strong communication, organizational, problem-solving, time-management, and relationship-building skills.

Culture & Benefits

  • Work in a global clinical research and healthcare intelligence organization.
  • Collaborate with study teams, investigators, clients, managers, and clinical research sites.
  • Support the development and delivery of innovative medical treatments and improved patient outcomes.

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