Clinical Research Associate Job in Alkem Laboratories Ltd

Clinical Research Associate

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Job Summary

  • Participate in site nomination process; perform an evaluation of site capability and make recommendations for inclusion in clinical trial.
  • Assume ambassadorial role to facilitate communication between sites and Key Novartis line
  • Functions to increase value proposition to investigators.
  • Monitor the status of site budget and contract negotiations as well as the collection and review of essential documents.
  • Ensure that study start-up activity and any amendments are conducted and completed on time, including preparation of IRB/EC submission packages, working with regulatory affairs for Health Authorities submissions.
  • Ensuresiteinitiation and training activities.
  • Ensure monitoring visits are performed according to the monitoring plan.
  • Manage recruitment implementing appropriate contingency plans as needed verification, AE and SAE reporting, protocol, drug accountability etc.). Resolve deviations to standard by remedial action and training.
  • Author study monitoring reports. Consistently read/review the content of all monitoring visit reports for the assigned trial. Also, identify trends and issues. Appropriately escalate issues in a timely manner and ensure resolution.
  • Ensure that the data query resolution processes are performed (both at Site and with Data
  • Management).
  • Assist in TCF completion at different milestones.
  • Mentor/coach monitors and sites as required.
  • Author SOPs as required.
  • Ensure all operational aspects are on schedule.
  • Communicate with field monitors on a regular basis to assure proper adherence to protocol, timelines and other trial related topics.
Experience Required :

2 to 7 Years

Vacancy :

2 - 4 Hires