Rohit Shete, Ccra
About Rohit Shete, Ccra
Rohit Shete is an Associate Director of Clinical Operations at CytomX Therapeutics, with a background in clinical project management and research spanning over 15 years. He has held key roles at several organizations, including FibroGen and Sangamo Therapeutics, and possesses extensive experience in managing clinical studies across various phases.
Current Role at CytomX Therapeutics
Rohit Shete serves as the Associate Director of Clinical Operations at CytomX Therapeutics. He has held this position since 2022, contributing to the company's clinical operations in South San Francisco, California. In this role, he oversees various aspects of clinical studies, ensuring compliance with regulatory standards and efficient management of clinical trials.
Previous Experience in Clinical Operations
Before joining CytomX Therapeutics, Rohit Shete accumulated significant experience in clinical operations. He worked as a Senior Clinical Trial Manager at FibroGen, Inc. from 2015 to 2021 and at Sangamo Therapeutics, Inc. from 2021 to 2022. His earlier experience includes a role as Clinical Project Manager at KlinEra Global Services from 2008 to 2015 and as a Clinical Research Associate at Raptim Research Ltd. and Lambda Therapeutic Research between 2006 and 2008.
Education and Certifications
Rohit Shete studied Medicine at the University of Mumbai from 1995 to 2000. He also achieved a Post Graduate Diploma in Clinical Research (PGDCR) from ICTCR during the same period. Additionally, he holds the Certified Clinical Research Associate (CCRA) designation from ACRP, which reflects his expertise in clinical research practices.
Expertise in Clinical Trials
Rohit Shete has extensive experience managing clinical studies across all phases, from Phase I through Phase IV. He possesses a strong understanding of ICH-GCP and FDA regulations, supported by his background as a licensed physician in India. His expertise includes managing vendor relationships with various stakeholders such as CROs, IXRS, Central Labs, Imaging, and Central IRBs.
Background in Clinical Research
Rohit Shete has a solid foundation in clinical research, having worked in various capacities since 2006. His roles have involved extensive monitoring and co-monitoring of clinical trials, as well as collaboration with cross-functional groups within clinical operations. This diverse experience has equipped him with a comprehensive understanding of the clinical research landscape.