Regulatory Affairs Coordinator
Vor 4 Tagen
F. Hoffmann-La Roche Gruppe is dedicated to providing an inclusive and accessible environment for all candidates.
We are seeking a highly skilled Regulatory Affairs Coordinator to join our team in Switzerland.
Your Key Responsibilities :
- Setting up and monitoring studies, completing reports, and maintaining documentation
- Submitting protocol, consent documents for ethics/IRB approval, and preparing regulatory submissions
- Taking responsibility for study cost efficiency
- Preparation and review of study documentation and feasibility studies for new proposals
- Potential to assist in training and mentoring fellow CRAs
Key Qualifications :
- At least 2 years of monitoring experience in phase I-III trials as a CRA
- Degree in medicine, science, or equivalent
- Previous monitoring experience in medium-sized studies, including study start-up and close-out
- Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
- Excellent written and verbal communication in German, French, or Italian
- Ability to work to tight deadlines
- Availability to travel at least 60% of the time (international and domestic) and possess a valid driving license
Our Benefits :
We offer a competitive salary and a range of additional benefits, including annual leave entitlements, health insurance offerings, retirement planning options, and a global employee assistance program.
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