Clinical Research Associate - Medical Device
About the role
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- Independent, proactive work to set up and monitor studies, complete reports and maintain documentation
- Submitting protocol, consent documents for ethics/IRB approval, as well as preparing regulatory submissions
- Managing sponsor generated queries
- Taking responsibility for study cost effectiveness
- Preparation and review of study documentation and feasibility studies for new proposals
- Potential to assist in training and mentoring fellow CRAs
- University degree in life science or related discipline OR RN/LPN with 4 years related experience
- Minimum 12 months of onsite monitoring experience
- 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
- Ability to work to tight deadlines
- Availability to travel at least 65-70% of the time
Application process
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