Rutuja Ghule

Experience

1. Clinical Research Coordinator

   Kolhapur Cancer Centre Kcc

   May 2024 — Present · Maharashtra, IN

   Supporting oncology clinical trials across multiple indications including solid tumors, oral cancer and other type of cancers.• Hands-on experience across Phase I, II, and IV clinical trials, including BA/BE studies.• Actively involved in study start-up, execution, and close-out activities in compliance with ICH-GCP, protocol, & regulatory guidelines• Completed 50+ feasibility questionnaires, assessing site capability, patient availability, and infrastructure• Coordinated and attended 20+ Site Qualification Visits (SQVs) & Site Initiation Visits (SIVs)• Managed and maintained Trial Master File (TMF) and Investigator Site File (ISF) ensuring audit-ready documentation• Prepared, reviewed, and tracked regulatory and IEC submissions including initial submissions, amendments, and continuing reviews• Served as primary liaison between Principal Investigator, CRO monitors, sponsors, and cross-functional hospital teams• Supported patient screening, informed consent, enrollment, and follow-up across oncology studiesCoordinated and assisted in blood sample collection and biopsy collection studies as per protocol requirements• Managed and reported 12+ Serious Adverse Events (SAEs) in accordance with regulatory timelines and sponsor SOPs• Ensured accurate CRF/eCRF data entry, timely query resolution, and data quality• Supported 8+ QA audits and 5+ sponsor audits, contributing to inspection readiness & compliance• Assisted during monitoring and close-out visits, ensuring CAPA implementation & documentation completion• Maintained study logs including screening, enrollment, AE/SAE, IP accountability, delegation & training logs• Coordinated with pharmacy for investigational product receipt, storage, dispensing & accountability• Supported AI-based clinical application study in oral cancer, assisting in imaging, data collection, protocol adherence & site coordination• Ensured subject safety, confidentiality & protocol compliance throughout the trial lifecycle

Education

• Progressive Education Societys Modern College of Arts, Science and Commerce, Shivajinagar, Pune 411005

  Bachelor's degree, Biotechnology

• GS Medical College & KEM Hospital, Mumbai

  Master of Science - MS, Pharmaceutical Medicine