Subrata Dey Email & Phone Number

Experience supervising multiple projects as a Clinical Research Coordinator in the fields of gastroenterology, pulmonology, ophthalmology, and oncology. Managed various phases of clinical trials, including Phase 2, Phase 3, Phase 4, and bioavailability/bioequivalence (BA/BE) studies, ensuring adherence to protocols and regulatory standards. Collaborated closely with principal investigators, sponsors, and stakeholders to ensure the smooth execution of clinical trials. Proficient in ICH-GCP guidelines and FDA regulations, maintaining strict regulatory compliance. Handled the trial master file (TMF) and ensured proper documentation and organization as per regulatory standards. Managed patient recruitment, informed consent processes, and data collection with a focus on accuracy and ethical conduct. Maintained meticulous study documentation and records, contributing to the success of clinical trials. Addressed and resolved operational challenges promptly, ensuring efficient trial progress. Utilized clinical trial management systems effectively. Demonstrated excellent communication and problem-solving skills, fostering positive relationships with study participants and team members. Adept at clinical data management, including data entry, validation, and quality control. Having the experience of handling electronic data capture (EDC) systems and clinical trial management systems (CTMS).Ensured data integrity and compliance with regulatory standards throughout the clinical trial process. Attended sponsor QA audits, ensuring compliance and readiness for external evaluations

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  Clinical Research Coordinator-I

  Indoriv Clinical Private Limited

  Sep 2022 - Present - Kolkata, West Bengal, India

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  Kalinga University, Raipur

  Pharmaceutical Sciences