Clinical Research Professional
Há 7 dias
Clinical Research Associates (CRAs) play a vital role in the success of our clinical trials at ICON. We are currently seeking an experienced CRA to join our team as a Senior CRA/CRA II.
We pride ourselves on our collaborative environment, where you will work closely with a talented group of CRAs to identify and select investigational sites for clinical studies in phases II – IV. As a CRA, you will be responsible for ensuring adherence to applicable regulations and principles of ICH-GCP.
Responsibilities:- Coordinate activities to set up and monitor a study, completing accurate study status reports and maintaining study documentation
- Submit protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested
- Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required
- Balancing sponsor generated queries efficiently and responsible for study cost-effectiveness
- Dependent on level of experience, you may assist in training and mentoring less expert CRAs and/or lead CRAs working on international projects
- 18 months+ of independent monitoring experience in phase I-III trials as a CRA, working for a CRO or pharma company
- Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data
- You will possess excellent written and verbal communication skills in Portuguese and English
- Ability to produce accurate work to tight deadlines within a pressurized environment
- You will be asked to travel as part of the position within Portugal and should possess a valid driving license
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Clinical Research Statistician
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