CTC :2,25,000 - 3,75,000 P.A
- Working knowledge in all areas of research including GCP, IRB protocol submission, Notifications and safety reporting.
- Conducting Feasibility assessments at sites for conduct of clinical trial.
- Assisting the investigator for conducting all study related activates, Identification of patients for the study. and follow-up with CRA for various concerns of trial related activities.
- Helping the investigator in achieving the recruitment goals of various trials and planning and conducting the follow-ups of the recruited patients as per study protocol, ICH GCP and all applicable regulatory guidelines
- Assisting the investigators in resolving in DCF's and helping CEVA Documents submission during cardiac related SAE and communicating with medical monitors in respective of any safety issues
- Proven project management abilities with capacity to train on different issues problem solving, mean time updating study related activities and the global news during ongoing trials, able to manage multiple responsibilities without compromising on detail or quality.
- Training the team on the Protocol, Handling and maintaining Study medication, Study related procedures, filling of CRF's.
- Regular update of safety issues in EDC/CRF and notifications to EC and to regulatory body for notifying Appendix11.
- Management and regular update of Trial master file and essential documents.
- Internal Monitoring of the studies conducted at site.
- Data entry, analysis and interpretation.
- Preparing the study report.
- Meet EC Chairperson/Member Secretary and coordinate smooth operations for Submission/Approval/Notification from site.
Coordinate with sites to improve the performance.
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