Tushar M Biswas
SMA / In-house CRA -Icon plc
- Role
- Sma In-house Cra at ICON plc
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Tushar M Biswas
Transforming clinical research challenges into streamlined solutions—that\'s what drives…
Experience
Sma In-house Cra
Jan 2024 — Present · Bangalore, IN
Act as primary site contact/liaison for study and site management issue including addressing site/ protocol questions, managing study supplies.Working in Oncology-Phase-I, II and Remote Monitoring visit call with PI and Study coordinator to discuss on Site health, PI oversight, Subject recruitment, Perform data review inclusive of site and subject level data, review delegation, temperature,Master IP and subject IP inventory logs, ensure timely and complete data entry and answer query by site in EDC and various vendor systems. Preparation of off site Trip Report and follow up letter that discuss during call.Complete essential documents collection and review throughout the study lifecycle inclusive of site activation and perform routine quality checks to ensure all the essential documents are in place.Act as the main point of contact for regulatory submission-related activities including Protocol, IB, ICF, safety reporting: other site SUSAR, Line listing and DSUR.Tracking of site submission, communication, and milestone update in CTMS.Customization of site specific ICF (Informed Consent form).Maintain site clinical trial master file (TMF).Set-up and maintain site related data in applicable clinical system according to the procedure and guidelines.Overall support to the study sites and clinical project teams engaged in clinical research studies adhering to applicable protocol, SOPs, and regulatory and practice requirement (ICH and GCP). Assign trainings to site staff from the client portal.Assist various vendors for IP shipment to the sites by reviewing and approving the invoice and providing custom clearance documents. Support CRA in multiple tasks to close follow-up action items from previous monitoring visits.Maintain the overall compliance of the team in clinical research by completing all necessary assigned training.
Education
Bangalore University
Master of Science - MS, Biotechnology
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