
Clinical Research Associate Specialist
2 days ago
About this role:
We are seeking a clinical research associate to join our team.
Key Responsibilities:
- AUTHOR and analyze clinical trial documents, working with key clinical documents like protocol, informed consent form, clinical study report, summary of clinical safety/efficacy, access evidence dossier, statistical analysis plan, and more.
- Create, validate, and refine prompts for AI-assisted document generation, applying knowledge of clinical trial phases, study design, and drug development.
- Maintain compliance with global regulatory standards (FDA, EMA, ICH-GCP) and utilize medical terminologies and ontologies for clarity and consistency.
- Ensure quality control and timely delivery of assigned tasks, collaborating with cross-functional teams to improve document accuracy and prompt effectiveness.
- Provide regular updates and flag risks to the project manager.
The ideal candidate will have 1-5 years of experience and any graduation degree. The role is hybrid and contract-based with an immediate - notice period. There are two rounds of technical interviews.
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