3 дня назад
Clinical Research Associate (CRA)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Associate (CRA) (Clinical Trials): Coordinating clinical trial activities, maintaining trial documentation, and supporting regulatory submissions with an accent on ICH-GCP compliance, clinical data integrity, and inspection readiness. Focus on updating trial registries, managing the Pfizer Trial Master File, organizing study documentation, and improving processes for clinical trial operations.
Location: Remote in Argentina
Company
develops medicines and therapies while supporting evidence-based medical decision-making and patient safety.
What you will do
- Coordinate and support clinical trial activities, project tasks, milestones, and deadlines.
- Maintain the Trial Master File in compliance with ICH-GCP and standard operating procedures.
- Update trial and site information in the Corporate Clinical Trial Registry.
- Support Clinical Trial Applications, ethics committee submissions, regulatory activities, protocols, and Informed Consent Documents.
- Maintain local tracking spreadsheets, prepare site materials, attend training programs, and identify process improvements for inspection readiness.
Requirements
- Bachelor’s degree in any field; no specific experience requirement stated.
- Ability to apply relevant standard operating procedures and introduce new ideas and knowledge.
- Strong prioritization, organizational, attention-to-detail, and deadline-management skills.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- Excellent written and verbal communication skills.
Nice to have
- Experience managing clinical trial and regulatory documents.
- Understanding of ICH-GCP and local regulations.
- Familiarity with clinical trial applications and electronic data capture systems.
- Experience using generative AI tools such as ChatGPT or Microsoft Copilot, including responsible AI, risk management, and ethical-use practices.
Culture & Benefits
- Full-time remote work from Argentina.
- Work in a structured environment with established procedures and colleague support.
- Opportunity to contribute to the development of new treatments and therapies.
- Equal employment opportunity for employees and applicants.
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