
Senior Clinical Research Lead
2 semanas atrás
We're seeking a seasoned Clinical Research Associate to join our team in a large-scale, fast-paced environment. As part of a close-knit group of highly qualified professionals, you'll play a crucial role in identifying, selecting, initiating and closing-out investigational sites for clinical studies in phases II - IV, ensuring adherence to applicable regulations and principles of ICH-GCP.
The Role:
- You will work independently and actively to coordinate activities to set up and monitor a study, completing accurate study status reports and maintaining study documentation.
- You will submit protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested.
- You will participate in preparing and reviewing study documentation and feasibility studies for new proposals as required.
- You will balance sponsor generated queries efficiently and be responsible for study cost-effectiveness.
- Dependent on level of experience, you may assist in training and mentoring less expert CRA's and/or lead CRA's working on international projects.
Requirements:
- 24 months+ of monitoring experience in phase I-III trials as a CRA.
- Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data.
- Excellent written and verbal communication in English.
- Ability to produce accurate work to tight deadlines within a pressurized environment.
- Travel at least 60% of the time.
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