Clinical Research Coordinator with one year of hands-on experience in managing clinical trials and investigator-initiated studies. Skilled in regulatory compliance, documentation, participant management, and data integrity. Proficient in trial monitoring, AE reporting, and cross-functional coordination. Committed to ethical, high-quality research, and improving patient care.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Trainee Clinical Research Coordinator
Bhaktivedanta Hospital and Research Centre
Mumbai
07.2024 - Current
Actively participated in three Site Initiation Visits (SIVs), taking the lead in preparation for one, and contributed to monitoring and close-out activities while maintaining clear communication with CROs or sponsors.
Supported the preparation and submission of essential documents to the IEC, regulatory authorities, and sponsors, ensuring timely approvals and amendments.
Ensured regulatory compliance through regular audit readiness, proper maintenance of the Trial Master File (TMF), Investigator Site File (ISF), eTMF, and completion of all logs and source documentation.
Assisted the principal investigator in the informed consent process, screening, and randomization of eligible participants.
Conducted study visits and data collection in compliance with the study protocol, institutional SOPs, and ICH-GCP guidelines, to ensure the rights and welfare of participants.
Proficient in EDC systems, source data verification, and query resolution, thereby ensuring high-quality data collection and integrity.
Facilitated timely and accurate documentation and reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs) in close coordination with the PI, and in line with regulatory timelines.
Maintained Investigational Product (IP) accountability through proper storage, dispensing, and reconciliation processes.
Maintained 100% patient compliance by strong patient engagement, and clear communication.
Laboratory Technician
GMERS Sola Civil Hospital
Ahmedabad
09.2019 - 12.2023
Performed blood collection, antibody screening, and compatibility testing; prepared & processed blood components for transfusion, and maintained lab equipment through routine calibration and checks.
Conducted quality control testing on incoming materials to ensure accuracy of results.
Managed inventory levels by ordering supplies and ensuring stock is available when needed.
Documented and reported test results accurately, maintaining detailed records in compliance with laboratory protocols.
Education
PG Diploma - Clinical Research
Bhaktivedanta Hospital and Research Centre
Mumbai
06.2025
DMLT - Paramedicine
Kanoria Centre For Medical Education
Gandhinagar
05-2018
B.SC - Microbiology
HNG University
Gujarat
05.2017
Skills
Detail-Oriented
Effective communication
Collaborative mindset
Critical thinking
Organizational skills
Time management
Data collection and management
MS Office
Clinical Studies
Phase IIIsponsor study conducted in assistance of PI Phase III breast cancer clinical trial sponsored by Pfizer, successfully recruited and managed four patients in the study
Phase III sponsor study conducted in assistance of PI Phase III type 2 diabetes mellitus clinical trial sponsored and coordinated by Sun Pharma
Investigator-initiated study indication: effect of CARICA-1 drug on patients undergoing chemotherapy, successfully recruited and managed 20 patients in the study
Clinical Research Coordinator at Bhaktivedanta Hospital & Research InstituteClinical Research Coordinator at Bhaktivedanta Hospital & Research Institute
Internship Clinical Research Coordinator at Bhaktivedanta Hospital and Research InstituteInternship Clinical Research Coordinator at Bhaktivedanta Hospital and Research Institute
Research Assistant at Research Center of the King Faisal Specialist Hospital & Research CentreResearch Assistant at Research Center of the King Faisal Specialist Hospital & Research Centre