
Chief Clinical Research Specialist
2 days ago
We are seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will play a critical role in the development and execution of clinical trials.
Required Skills and Qualifications- Author and analyze clinical trial documents.
- Work with key clinical documents such as 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.
- Apply knowledge of clinical trial phases, study design, and drug development.
- Maintain compliance with global regulatory standards (FDA, EMA, ICH-GCP).
- Utilize medical terminologies and ontologies for clarity and consistency.
- Ensure quality control and timely delivery of assigned tasks.
- Collaborate 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 experience in authoring and analyzing clinical trial documents, working with key clinical documents, creating and validating prompts for AI-assisted document generation, applying knowledge of clinical trial phases, study design, and drug development, maintaining compliance with global regulatory standards, utilizing medical terminologies and ontologies, ensuring quality control, collaborating with cross-functional teams, and providing regular updates.
OthersOur company specializes in digital engineering and IT services helping clients modernize their technology infrastructure, adopt cloud and AI solutions, and accelerate innovation.
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