Highlights:
- Position for research scientist for clinical trials; perform evaluation of site capability and make recommendation for inclusion in clinical trial.
- Assume ambassadorial role to facilitate communication between sites and Key Novartis line functions to increase value proposition to investigators.
- Facilitate preparation and collection of site level documents.
- Execute site initiation and training activities.
- Perform monitoring visits according to monitoring plan.
- Manage site drug supply management.
- Resolve site level update of technical systems (Clin Admin, EDC).
- Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc).
- Manage recruitment implementing appropriate contingency plans as needed.
- Assure continual GCP, ICH and Novartis SOP compliance (Informed consent process, Source data verification, AE and SAE reporting, IN, protocol, drug accountability etc.) Resolve deviations to standard by remedial action and training.
