Jinankoor Funde

Clinical Research Coordinator with 2.3 years of clinical research experience managing 3 clinical trials across multiple sites in Gujarat and Maharashtra, from site initiation through close-out. Skilled in ICH-GCP compliant trial conduct, Ethics Committee submissions, IP accountability, source document and CRF management, and EDC systems (Clinion). Adept at coordinating with CRAs, investigators, and sponsors to maintain protocol compliance, subject retention, and audit-ready documentation.

Brings together strong site operations experience with business development exposure in investigator identification and study feasibility assessment.

Clinical Research Coordinator & support to Business Development - Research Crest - Mumbai, India

(2024-07)

• Managed 3 studies simultaneous in diabetology and infectious diseases across 3 sites in Gujarat and Maharashtra, overseeing the full trial lifecycle from Site Initiation Visit (SIV) through Site Close-out Visit (SCV) in compliance with ICH-GCP and the New Drug and Clinical Trial Rules, 2019.
• Coordinated informed consent administration and re-consenting for 60+ enrolled subjects, ensuring documentation met regulatory and Ethics Committee requirements with zero consent-related findings across 20 sponsor/monitoring visits.
• Maintained Investigator Site Files and Investigational Product accountability logs to audit-ready standard, supporting 20 monitoring visits and 2 Ethics Committee inspections with no major findings.
• Tracked subject visit compliance against protocol schedules, achieving a subject retention rate of 83% across active studies.
• Reviewed and resolved EDC (Clinion) data queries within 3-day average turnaround, supporting on-time database milestones.
• Prepared and submitted Ethics Committee applications, amendments, and safety notifications, meeting 100% of required regulatory timeframes across 7 submissions.
• Documented and reported protocol deviations and adverse events to Ethics Committees, sponsors, as applicable within mandated timeframes.
• Supported site activation for new studies by assisting in the establishment of clinical trial units at 3 partner hospitals.

Business Development Executive - Research Crest - Mumbai, India

(2024-07)

• Identified and engaged prospective hospitals and investigators to expand the organization's clinical trial site portfolio.
• Assessed patient population and recruitment potential with investigators to strengthen study feasibility evaluations.
• Developed customized proposals and client presentations to support new business acquisition with hospitals and sponsors.

Post Graduate Diploma in Advanced Clinical Research - Advanced Clinical Research - National Institute of Management & Research (2024)

Bachelor of Science - Zoology - Kirti M. Doongursee College of Arts, Science & Commerce (2023)