Harini Kothari
About Harini Kothari
Harini Kothari is a Senior Clinical Scientist at Bristol Myers Squibb with extensive experience in clinical research and project leadership.
Current Position at Bristol Myers Squibb
Harini Kothari serves as a Senior Clinical Scientist at Bristol Myers Squibb. In this high-responsibility role, she actively engages in clinical trials and study start-ups. Her work includes protocol and amendment writing as well as the development of Informed Consent Forms (ICF) in collaboration with Medical Writing. Kothari's activities further encompass the comprehensive assessment of innovative trial designs along with the Medical Director and Clinical Development Lead.
Previous Roles in Clinical Research
Before her current position, Harini Kothari gained substantial experience in various clinical research roles. For two years, she served as a Clinical Scientist at Bristol Myers Squibb, preceded by a similar role at Merck under ExecuPharma. She also worked as a Clinical Project Leader at BD in Franklin Lake, NJ, and a Senior Clinical Research Scientist at Northwell Health. At Mount Sinai Health System, Kothari was a Research Clinical Data Coordinator, and she also held positions at OSI Pharmaceuticals and LIU as a Research Assistant.
Educational Background
Harini Kothari holds a Master of Science (MS) in Molecular Biology from LIU Brooklyn, completed from 2006 to 2008. She also earned a Master of Biology in Microbiology from Hemchandracharya North Gujarat University, following a Bachelor of Science (BS) in Microbiology from the same institution. Furthermore, she obtained a Diploma in Pharmacy from Hemchandracharya North Gujarat University.
Experience in EU-CTR Protocols
Harini Kothari has specialized experience in the EU-CTR protocol and amendment submission processes. Her work has involved dealing with RFI Part I & II responses and document redaction. This expertise contributes significantly to her ability to manage and streamline clinical trial processes, ensuring compliance with regulatory standards.
Training and Development Contributions
Kothari has been actively involved in developing and presenting training materials at Investigator Meetings (IM) and Site Initiation Visits (SIVs). She has educated team members, including Clinical Research Associates (CRAs), enhancing their understanding and proficiency in clinical trial operations. Additionally, she collaborated with Data Managers to develop comprehensive Data Review Plans (DRP).