Shivraj Choudhary

• Coordinating with Ethics committee (submission and notifications/ approval letters), sponsor/CRO, Pl
• Handling and Coordinating all Ethics committee activities 
Drafting Meeting Minutes, Circulating to all EC members
• Assisting PI in all Trial related activities ( Informed consent process, Subject screening and scheduling patient visits, Audio visual Recording)
• Maintaining clinical trial related documents at site including Site Master File as per regulatory guidelines
• Completion of all source documentation for the monitoring visits and complete the paper and eCRF as per source & Transcribe CRF's in consultation with the PI/Investigator 
• Packaging and shipping of blood samples to central lab/ local lab 
• Complete patient visits as per protocol requirements 
• IP Dispensing to subjects under supervision of PI through IWRS, IVRS and maintaining the accountability and reconciliation 
• Assisting in and performing timely resolution of Queries and DCF’s
• Facilitate , prepare and assist during site initiation, monitoring visits, protocol prescribed and other necessary patient visits, Sponsor visits, audits (sponsor, CRO, DCGI) 
• Ensuring timely availability of Lab kits and other clinical trial supplies and ensuring IP is appropriately stored, maintaining temperature logs where necessary. 
• Reporting of SAE/AE to sponsor, Ethics committee and to DCGI in compliance with regulatory guidelines
• Faced DCGI Audit in June 2018 ( Sponsor- Bharat Serum
Monitoring the IP inventory, SIF and all the activities at site
Experience in Handling Phase III Gynecology studies

• Coordinating with Ethics committee (submission and notifications/ approval letters), sponsor/CRO, Pl
• Handling and Coordinating all Ethics committee activities 
• Assisting PI in all Trial related activities ( Informed consent process, Subject screening and scheduling patient visits, Audio visual Recording)
• Maintaining clinical trial related documents at site including Site Master File as per regulatory guidelines
• Completion of all source documentation for the monitoring visits and complete the paper and eCRF as per source & Transcribe CRF's in consultation with the PI/Investigator 
• Packaging and shipping of blood samples to central lab/ local lab 
• Complete patient visits as per protocol requirements 
• IP Dispensing to subjects under supervision of PI through IWRS, IVRS and maintaining the accountability and reconciliation 
• Assisting in and performing timely resolution of Queries and DCF’s
• Facilitate , prepare and assist during site initiation, monitoring visits, protocol prescribed and other necessary patient visits, Sponsor visits, audits (sponsor, CRO, DCGI) 
• Ensuring timely availability of Lab kits and other clinical trial supplies and ensuring IP is appropriately stored, maintaining temperature logs where necessary. 
• Reporting of SAE/AE to sponsor, Ethics committee and to DCGI in compliance with regulatory guidelines

Worked on Vaccine Trials