9 часов назад
Clinical Research Associate
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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