обновлено 2 дня назад
Clinical Research Associate (Biotech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Associate (Biotech) (Clinical Trials): Managing and monitoring multi-country clinical trials with an accent on site selection, study compliance, data quality, and patient safety. Focus on conducting monitoring visits, verifying source data, managing investigational products, maintaining trial documentation, and supporting audits and inspections.
Location: Bulgaria
Company
is an international, science-driven biotech CRO founded in Italy in 1998, providing full-service clinical trial management and scientific, regulatory, statistical, and pharmacovigilance support.
What you will do
- Identify, assess, initiate, monitor, and close out investigational sites.
- Conduct feasibility, pre-study, initiation, monitoring, and close-out visits.
- Ensure compliance with study protocols, SOPs, ICH-GCP, ISO 14155, and applicable regulations.
- Verify source data, maintain data quality, and monitor patient recruitment and safety reporting.
- Manage investigational product handling, storage, and accountability.
- Maintain TMF/eTMF and Investigator Files, prepare monitoring reports, collaborate with sponsors and site staff, and support audits and inspections.
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 required.
- Proficiency with Microsoft Office and strong organizational, communication, and problem-solving skills.
- Ability to work independently and collaboratively.
Culture & Benefits
- Competitive salary with additional benefits and bonuses.
- Professional development opportunities within an expanding international CRO.
- Work alongside specialized professionals supporting multi-country clinical trials and complex scientific projects.
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