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9 часов назад

Clinical Research Associate

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:
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TL;DR
Clinical Research Associate (Clinical Trials): Managing and monitoring clinical trials across site selection, initiation, monitoring, and close-out with an accent on ICH-GCP compliance, data quality, and patient safety. Focus on source data verification, patient recruitment, investigational product accountability, adverse event reporting, and supporting audits and inspections.

Location: United States

Company

hirify.global is an international, science-driven biotech CRO founded in Italy that provides clinical trial management and related scientific, regulatory, pharmacovigilance, and technology services for multi-country studies.

What you will do

  • Identify, assess, and initiate investigational sites.
  • Conduct feasibility, pre-study, initiation, monitoring, and close-out visits.
  • Ensure compliance with protocols, SOPs, ICH-GCP, ISO 14155, and applicable regulations.
  • Perform source data verification, maintain data quality, and monitor patient recruitment.
  • Manage adverse event and protocol deviation reporting, investigational product accountability, and study documentation.
  • Write monitoring reports, collaborate with sponsors and site staff, support audits and inspections, and mentor junior CRAs.

Requirements

  • Degree in a scientific field.
  • At least 2 years of CRA or clinical trial monitoring experience.
  • Strong knowledge of ICH-GCP, ISO 14155, and clinical trial processes.
  • Good English proficiency required.
  • Microsoft Office skills and strong organizational, communication, and problem-solving abilities.
  • Ability to work independently and collaboratively.

Culture & Benefits

  • Competitive salary with benefits and bonuses.
  • Opportunity for professional development within an expanding international CRO.
  • Work with specialized professionals across clinical trial management, medical writing, scientific and statistical consultancy, regulatory activities, and pharmacovigilance.

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