Expression Of Interest/Bid Towards Engagement Of Clinical Research Organization For Vaccine Trial , Project Management , Develop Project Management Plan , Develop Study Monitoring Plan , Develop Monitoring Report System , Development Of Auto-Tracking Tools , Maintenance Of Tracking Tools , Provide Oversight Team , Support Query Resolution Between The Central Data Management Team And Site Team , Study Initiation , Site Preparation , Set-Up Study Master File , Organization Of Site Initiation Visits , Facilitate Travel And Report Generation , Site Initiation Meetings , Site Monitoring , Routine , Periodic & For Call Site Monitoring , Undertake Source Document Verification Through Site Visits , So That Complete Verification Is Done , Consent Form Review As Per Icmr Ethical Guidelines And Cdsco Guidelines , Review Of Investigational Product Records And Accountability , Help In Shipment Of Investigational Product To The Sites Including Maintenance Of Cold Chain And Other Required Conditions , Verify Site Compliance To Protocol And Gcp Requirements , Including Continuing Ethics Committee Requirements , Pharmacovigilance Monitoring Including The Reporting To Appropriate Regulatory Authorities , Provide Medra Coding Support For Safety Data ( Sae/ Ne ) , Sae Review And Helping The Investigator With Respect To Causality And Compensation , Review Of Sae Reporting Timeline As Per Applicable Regulatory Requirement , Monitoring Reports , Facilitate Site Preparation For Any Other Monitoring By The Sponsor , Audit Or Inspections , Supply Management , Site Supplies Management ( Check Supplies Requirement Including The Kits ) , Ip Management ( Check The Requirement Of Ip At The Site And Its Storage ) , Ensure Appropriate Pharmacy Conditions Including Temperature Recording , Specimen / Imp Tranfer With Appropriate Temperature Maintenance , Study Close Out Activities , Support For Final Archival Of The Study Documents , Study Close Out Report , Training , Training Of The Study Team Members In Ich Gcp And Icmr/Cdsco Guidelines Relevant To The Study , Training Of The Study Team Members In Protocol , Logistics , Preparation And Maintenance Of Site Master File , Preparation And Maintenance Of Trial Master File , Printing Of Icfs , Printing Of Crfs , Diary Cards , Preparation Of Participant Binders , Distribution/Delivery And Maintenance Of All Study Related Documents In/ To Respective Sites In Timely Manner . , Applicable Gst
