Vinodkumar Vora Email & Phone Number

13 years of professional experience including clinical research, regulatory affairs, medical affairs & general management experience Hands on experience of project management, site feasibility, follow up, closure, SOP preparation, BA/BE execution & monitoring, Team management, business development.Specialties: Clinical trials, Project Management, Business Development.

• Operational Specialist

  Concept Clinical Services

  Nov 2010 - Present - Surat Area, India

  •Good understanding of ICH-GCP, Schedule Y & Clinical Drug Development process•Faced GCP Inspection conducted by CDSCO•Attended ICH-GCP, Protocol & RDC/EDC training conducted by Novartis, Lambda,Veeda & Quintiles•Faced various SSV, SIV, Monitoring & Close-out Visits for various Trials•Internal Monitoring: Prepare Site for Visits & Audits, Review of all trial documents & data•Conduct feasibilities & Train new joined candidates for all trial procedures•Compilation of trial documents (Feasibility etc.) before SIV for all trials•Prepare/Update site SOP and Negotiate trial budgets with CRO/Sponsor as per the PI/Site requirement•Communicate with CRO/Sponsor and PI/Legal Deptt for Review & Signing of CTA•Update Site Trial Status Tracker & Follow up from site team for updated SMF of all trials•Coordinate with EC for Submission, Approval, Notification & Queries•Work with Monitors for training of site team on Lab procedures and Review of trial documents & data•Discuss strategies of Screening, Recruitment & Retention of subjects with the PI & Site Team•Assist the discussion of ICD (PIS & ICF) to the subjects and discuss in detail of Patient Diaries•Follow up from site team for all Central Lab procedures: Sampling, Shipment of Samples by the designated courier & timely receipt of Reports•Confirmation of IP shipments, Enrolment of Subjects & Drug Dispensing by IVRS/IWRS•Follow up from site team for logs: Temperature, Delegation, Screening, Enrolment, Drug Dispensing•Follow up from site team for timely completion of the source document and ensure that all information required for the CRF/eCRF are present in the source document•Completion of CRF/eCRF within time & Discrepancy/query management indicated by Data Management, AE/SAE reporting in timely manner•Accountability of IP and completion of Drug Accountability Log•Inventory management of trial materials: Ordering, Tracking, Supply, Storage & Reconciliation