Divya Budhwani
Clinical Research Coordinator @Sahyadri Hospitals
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WORK HISTORY
Clinical Research Coordinator @Sahyadri Hospitals
Pune, IN
Maintained inspection-ready ISF and eTMF through continuous reconciliation andquality checks.• Prepared source documentation for monitoring visits, supporting timely completion ofCRA visit activities.• Performed SDV and SDR to ensure accurate CRF-source alignment and faster queryresolution.• Supported AE, SAE, and SUSAR documentation with timely escalation in line withregulatory requirements.• Managed investigational product accountability including reconciliation, temperaturemonitoring, and protocol compliance.• Assisted in EC and QA audits by preparing regulatory documentation and addressingaudit findings.
EDUCATION
ADARSH COLLEGE OF PHARMACY, SANGLI
High School Diploma
Bharati Vidyapeeth
Bachelor of Pharmacy
Shivaji University, Kolhapur
Bachelor of Pharmacy - BPharm, Pharmacy
Bharati Vidyapeeth English Medium School
High School Diploma
ABOUT DIVYA BUDHWANI
Detail-oriented Clinical Research professional with hands-on experience supporting Phase and Phase IV clinical trials in oncology and gastroenterology settings. Currently pursuing an Advanced Diploma in Clinical Research, Clinical Data Management, and Pharmacovigilance, with a strong foundation in GCP-compliant clinical trial operations.Experienced in maintaining inspection-ready ISF and eTMF, supporting monitoring visits through accurate source documentation, and performing SDV/SDR to ensure data integrity and timely query resolution. Proficient in AE, SAE, and SUSAR documentation, investigational product accountability, and regulatory compliance in alignment with ethical and regulatory requirements.Demonstrated ability to support CRA activities, ethics committee processes, and audit readiness, along with developing SOPs and operational templates to enhance documentation quality. Highly motivated to build a career in clinical research, pharmacovigilance, and drug safety, bringing strong analytical skills, teamwork, and effective communication to clinical trial environments.
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