Clinical Research Associate
Há 6 dias
Job Title: Clinical Research Associate
The In-House CRA performs critical site activation and maintenance tasks, ensuring compliance with sponsor and ICON protocol, SOPs, ICH/GCP guidelines, and applicable regulatory requirements. Key responsibilities include essential document collection and review, clinical status tracking, and site management activities.
Key Responsibilities:
- Perform routine essential document collection, review, and negotiation to ensure site activation and maintenance.
- Recruit study sites, ensuring accurate tracking and documentation of clinical data throughout the project lifecycle.
- Complete submissions and notifications to regulatory authorities, ethics committees, and other bodies.
- Collaborate with patient management teams to address patient inquiries and issues.
- Conduct clinical data review, query creation, query resolution, and site management communications as outlined in study plans and SOPs.
Requirements:
- Bachelor's degree in a clinical, science, or health-related field.
- Previous experience in clinical research with ethics submissions.
- Knowledge of ICH and local regulatory authority drug research and development regulations.
- Advanced English language proficiency, with fluency in the host country language.
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