Pharma Clinical Research Job Vacancy @ Teva – Apply
Pharma Clinical Research Job. Pharma Associate Post. Teva hiring Pharmacy candidates for the post Operator.Teva Hiring Undergraduate Pharmaceutical Science candidates. Teva is a global pharmaceutical leader and the world’s largest generic medicines producer committed to improving health.
Job Title: Clinical Research Assoc
Qualification: M.Pharm, B.Pharm. MBBS, M.Tech (Biotech), M.Sc, B.Sc along with some diploma in clinical research etc)
Experience: Prior on-site monitoring experience of 2 to 5 years on Phase I/II/III clinical trials in the capacity of CRA either in CRO or a biopharmaceutical company.
Job Description
Site Monitoring
- Regulatory/ethics submission of CT as per timelines and to ensure regulatory documents are available, complete and current.
- In coordination with the project manager and/or medical monitor, perform study site selection visits. Participate in/conduct investigator’s meeting and site initiation visits.
- To identify, define, coordinate and conduct site study training.
- In coordination with the project manager, provide oversight of all study-related activities.
- To perform regular monitoring visits to site and prepare monitoring reports
- To ensure the compliance to ICH-GCP guidelines, local & international regulations (i.e. DCGI, FDA) and applicable SOPs.
- To verify the case report forms and source data according to the monitoring plan
- To ensure that the clinical trial supplies are appropriately handled and adequately maintained at the site as per the project requirements.
- Evaluates the speed of recruitment and propose alternative solutions if the predefined objectives are not met, either in the terms of patient number or timelines.
- To resolve all data queries or other study related queries from the site within timeframe.
- Conduct site close out and assure appropriate archival of controlled documents.
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