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Clinical Research Associate
2 semanas atrás
At our organization, we strive to create an inclusive environment that fosters innovation and excellence.
We welcome talented individuals to join us in shaping the future of clinical development.
The Role:- Working independently to coordinate activities for setting up and monitoring studies, completing accurate study status reports and maintaining study documentation
- Submission of protocols and consent documents for ethics/IRB approval, as well as assisting in preparing regulatory submissions as requested
- Participation in preparing and reviewing study documentation and feasibility studies for new proposals as required
- Efficient balancing of sponsor-generated queries and responsible for study cost-effectiveness
- 24 months+ of monitoring experience in phase I-III trials as a CRA
- Knowledge of ICH GCP guidelines and expertise to review and evaluate medical data
- Excellent written and verbal communication skills in English
- Ability to produce accurate work under tight deadlines within a pressurized environment
- Frequent travel expected (at least 60%)
- Monitoring experience in clinical trials
- ICH GCP knowledge
- Medical data evaluation
- Effective communication
- Time management
