LEE YE JIN

Summary

Dedicated Registered Nurse with a Bachelor's degree and over 2 years of clinical research experience in global Phase I–III oncology trials. Enhanced site compliance by resolving over 50 adverse event-related data queries daily, resulting in a significant compliance score improvement. Managed SAE reconciliation, IRB submissions, and clinical document quality control, achieving zero critical findings during internal audits.

Overview

Certification

years of professional experience

Work History

Clinical Research Coordinator

CM hospital

04.2026 - Current

Managed clinical trial conduct across full study lifecycle, ensuring compliance with ICH-GCP, KGCP, and study protocols to facilitate successful study outcomes.
Led site activation and budget management, preparing IRB submissions and reconciling contracts to ensure timely project delivery.
Developed and implemented SOPs for Clinical Trial Center, standardising site processes to ensure adherence to regulatory requirements and improve operational consistency.

Physician Assistant (PA)

ThanQ Seoul Medical Clinic

02.2025 - 03.2026

Delivered clinical expertise for study-specific tasks, ensuring accurate data reconciliation and verification of biopsy and post-operative care procedures.
Organised and verified patient documentation, including medical records, pathology reports, and diagnostic results, to enhance follow-up efficiency.
Facilitated oncology procedures to enhance clinical accuracy and patient safety., maintaining clinical accuracy and safeguarding patient data integrity.

Clinical Research Coordinator (oncology part)

Seoul National University Bundang Hospital

03.2022 - 03.2024

Prepared and submitted IRB applications, ensuring timely study activation.
Managed subject visits and documentation in compliance with study protocols, with zero critical findings in internal audits.
Coordinated communication between investigators, site staff, and internal departments to keep trials on track.
Resolved data queries and completed documentation within project timelines to support data integrity.
Identified site-level compliance issues and implemented corrective actions, improving site compliance scores.
Maintained audit-ready essential documents through ongoing reconciliation, in line with internal SOPs and regulatory guidelines.
Trained junior staff on ICH-GCP, study protocols, and site management practices.

Education

Bachelor’s degree - Nursing

Gachon University

Incheon, Republic of Korea

02-2020

GCP TRAINING

Skills

English : Immediate

- TOEIC score : 825

- Date : Nov 2024

KEY ACHIEVEMENTS

Data Resolution: Cleared 50+ Adverse Event (AE) data queries daily for a high-risk transition trial, elevating the site compliance score by over 3 levels within 6 months.
Audit Readiness: Achieved Zero Critical Findings during internal audits through essential document management and ICH-GCP adherence.
Trial management: Coordinated 12+ Phase I–III global oncology trials overseeing 100+ total enrolled patients and 40+ active ongoing and F/U subjects.