Sonia Keshwani
Summary
Focused Research Coordinator well-versed in study protocols, standard operating procedures, and general trial oversight. With over 3 years of experience in study start-up, participant recruitment, regulatory compliance, and excellent problem-solving skills with a detail-oriented nature. Strong interpersonal skills and ability to collaborate effectively with interdisciplinary teams. I am also dedicated to ensuring the ethical and efficient conduct of clinical research studies.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Research Coordinator
Weill Cornell Medicine
01.2024 - Current
- Develops and implements practices to ensure research efficiency by routinely analyzing and evaluating workflow.
- Coordinates the collection, compilation, documentation, and analysis of clinical research data from various clinical sites.
- Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies.
- Develops regulatory reports and associated documentation in accordance with SOPs and study specific processes.
- Prepares study related budgets for granting agencies. Negotiates study related budgets with various sites, departments, and sponsors.
- Research and develop recruitment strategies. Employs modeling and simulation tools to understand the current and projected outcome of recruitment techniques. Monitors and evaluates the success of varying subject recruitment techniques.
- Performs monitoring visits: pre-study, initiation, routine monitoring, and closeout visits.
- Develops policies and procedures pertaining to regulatory and monitoring processes.
- Leads regulatory educational training events for personnel at various sites.
Clinical Research Coordinator
Mount Sinai Hospital, Sinai Health System
01.2022 - 03.2024
- Recruitment of and obtaining consent from eligible patients for studies; performing study visits and required data collection for all subsequent study visits.
- Prepare REB/IRB and other regulatory documents necessary to conduct clinical research.
- Ensure smooth and efficient day-to-day operation of research and data collection activities in support of study protocols; data entry and query resolution as needed.
- Maintaining Trial Master Files, Preparing Research Ethics Board, and other regulatory submissions
- Planning and coordinating the initiation of research study protocols.
- Participate in monitor visits by sponsors, Support Research Assistants and Research Students, and provide training as needed with support from the Research Manager
- Support investigators in the development and finalization of manuscripts and new research proposals.
- To develop and present material for publication using strong written and verbal communications skills.
Perioperative Coordinator
Mount Sinai Hospital, Sinai Health System
09.2019 - 12.2021
- Responsible for receiving, collating, copying, filing, transferring and entry of booking requests into the scheduling and patient computer systems.
- Scheduling accurately, all surgical procedures in the O.R scheduling system.
- Coordinates with surgeons and their secretaries to make sure procedures are accurate.
- Coordinates with NUA and Anesthesia coordinators of changes or additional surgical schedule.
- Generates and distributes reports and schedules from the scheduling system.
Education
Graduate Certificate, Canada - Clinical Research
The Michener Institute
Toronto, ON03.2023
Associate of Science - Medical Assistant
ASA College, New York
New York, USA 02.2018
Bachelor of Science - Health Sciences
University of Mumbai
Mumbai, India04.2013
Skills
- Strong knowledge of clinical research regulations, guidelines, and processes; such as FDA, ICH/GCP, Tri-Council Policy, Declaration of Helsinki, Health Canada TDP
- Proficient in Microsoft Office, electronic data capture (EDC), EPIC, REDCap, POWERCHAT, PROMs, DADOS, Cerner, and ISAAC systems
- Understanding about REB/IRB applications, maintenance of regulatory files and data entry
- Excellent organizational, communication, and interpersonal skills
- Ability to work independently and collaboratively in a team environment
- Detail-oriented and committed to producing high-quality work
- Time management and Problem-solving skills
- Clinical Laboratory skills including Phlebotomy, Finger puncture, Urinalysis
Certification
- Certified Clinical Research Coordinator (CCRC)
- ICH Good Clinical Practice (GCP)
- Health Canada Div5
- Biomedical Research Investigators and Key Personnel
- Cardiopulmonary Resuscitation (CPR)
- Health Insurance Portability and Accountability Act (HIPAA)
Timeline
Research Coordinator
Weill Cornell Medicine
01.2024 - Current
Clinical Research Coordinator
Mount Sinai Hospital, Sinai Health System
01.2022 - 03.2024
Perioperative Coordinator
Mount Sinai Hospital, Sinai Health System
09.2019 - 12.2021
Graduate Certificate, Canada - Clinical Research
The Michener Institute
Associate of Science - Medical Assistant
ASA College, New York
Bachelor of Science - Health Sciences
University of Mumbai
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