Clinical Research Associate Job in Alkem Laboratories Ltd

Clinical Research Associate

Alkem Laboratories Ltd 4+ weeks ago

Mumbai, Maharashtra
Not Disclosed
Full-time
Permanent

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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.