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.
- Author study monitoring reports.
- Perform data query resolution process (both at Site and with Data Management).
- Execute site closeout activities.
- May act as local (or global) CRA Lead, as assigned.
- Required Skills:
- Basic medical and business knowledge;
- Understands and can apply knowledge of clinical trial designs to trial execution;
- Knowledge and experience in international standards (GCP/ICH), international (FDA, EMEA)and local regulations;
- Expertise in communication, managing multiple priorities and computer literacy.
- Qualification: A degree in a scientific or health care discipline
Languages: Fluent English (oral and written). - Please apply online at: http://www.novartis.com/careers/job-search/brassring/index.shtml
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