Hyunmin Kim

• Monitoring Experience 4 Oncology IIT and 1 iron supplements IIT
• Study Progress and Issue Resolution
• Experience with Monitoring Visits and Report writing Across Various Institutions
• Data Accuracy and Record Completeness
• ISF and TMF Management
• Source Data Verification (SDV) and Query Resolution
• Adverse Event (AE) and Serious Adverse Event (SAE) Reporting and Management
• Budget Management Support
• Site Training on Research Protocol and Safety Procedures
• Effective Communication Skills with Site Personnel
• Managing regulatory documentation and the SAE, Midterm Review for IRB.
• Conducted clinical trial in accordance with protocol and recorded and monitored progress.
• Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
• Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
• Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.

• Managing the site activation of 3 SIT and 1 PMS.
• Conducting 30-subject screening, Verifying the I/E criteria.
• Performing data collection, entry, and maintaining accurate

Study data.

• Managing regulatory documentation and Submitting the SAE,

Midterm Review for IRB

• Communicating and collaborating on study requirements with the research team.
• Handling specimens.
• Internal Audit Institution QA experience
• Making workflow processes of Clinical trials.
• Participating in Global Investigator Meetings.
• Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
• Assessed patients eligibility criteria following strict adherence to inclusion/exclusion guidelines.