Yesha Naik
Clinical Research Coordinator Manager @Baps Pramukh Swami Hospital
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WORK HISTORY
Clinical Research Coordinator Manager @Baps Pramukh Swami Hospital
Surat, IN
o Management of Sponsor / CRO Submissions\\\\no Site Setup\\\\no Feasibility of sites\\\\no Sign the Service Agreement\\\\no Schedule Patient Visits\\\\no Coordinate and liaise with Sponsor / CRO for Monitoring visits, Audits, and Inspections and be present for the same\\\\no Assist Investigator to conduct Study as per Protocol, ICH – GCP, and applicable regulatory authorities\\\\no Initial Assessment of Inclusion / Exclusion Criteria\\\\no Patient registration/randomization\\\\no Liaise with Central Laboratory\\\\no Recruitment follow-up\\\\no Data Entry / CRF Completion\\\\no Query Resolution\\\\no Reporting AEs and SAEs\\\\no Manage and update the Investigator / Site File and Trial Master File\\\\no Monitoring of Research Coordinator working at different sites\\\\no Provide assistance to clinic staff by organizing projects\\\\no Working as a freelancer to obtain certification of DCGI (CDSCO) Registration, Re-registration, and NABH EC Certificate\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n
EDUCATION
Uka Tarsadia University
Bachelor of Pharmacy - BPharm, Pharmacy, First
Uka Tarsadia University
Master of Pharmacy, Pharmacology, First with Distinction
ABOUT YESHA NAIK
Experienced Clinical Research Coordinator with a demonstrated history of working in the hospital & healthcare industry. Skilled in Clinical Research Experience, Good Clinical Practice (GCP), Trials, Clinical Research, and Medicine at BAPS Hospital. Strong research professional with a Master\'s degree focused in Pharmacology from UKA TARSADIA UNIVERSITY.
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