Job for Clinical Research Associate at Teva | M.Pharm, B.Pharm

 

Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.  Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas.

Post : Clinical Research Assoc I

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.

Candidate Profile
• Doctorate, Master’s or Bachelor’s Degree. Major course of study must be Science or Health-related. (i.e. M.Pharm, B.Pharm. MBBS, M.Tech (Biotech), M.Sc, B.Sc along with some diploma in clinical research etc)
• Understanding of clinical research process and ICH GCP
• Basic understanding of the drug development process

Additional Information
Qualification : M.Pharm, B.Pharm. MBBS, M.Tech (Biotech), M.Sc, B.Sc

Location : Bangalore
Industry Type : Pharma
Functional Area : Research & Development
End Date : 20th July, 2019

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