Clinical Project Manager

• May 2023 - Present

Clinical Research Associate

• Jan 2022 - May 2023

▶ Ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews case report forms(CRFs), and communicates with clinical research coordinators 1. Establish the plan of clinical study or project 2. Execute clinical study or project (explored study/confirmatory study/research & development study etc.) - Explored study/Pre- and Post-approved study conducted by CRT - Project management throughout planning to end - Medical writing and management of Essential Documents related clinical study (Protocol/Case Report Form/Informed Consent Form/Clinical Study Report etc.) - Readiness and correspondence of IRB/Health Authority Review - Monitoring activity of clinical site during clinical study execution - Clinical study data quality, milestone and study/project budget management - CRO/Vendor and Clinical site management and communication - Comply with company SOP, local/global regulations (including KGCP) and requirements related clinical study/project - Issue management related clinical study or project 3. Support on process of product licensing by Health Authority 4. Scientific Review for technical document and article related clinical study/project 5. Ensure audit and inspection readiness of clinical studies including CAPA (Corrective Action and Preventive Action) management Show less

Registered Nurse

• Jan 2021 - Dec 2021

Registered Nurse(Surgical Nurse) ▶ work directly with a doctor and give assistance in whatever way is needed during the actual surgery 1. Assist surgeons in the operating room and serving as part of the surgically clean medical team handling instruments during an operation 2. work directly with doctors on the surgery, helping to control bleeding, watching for signs of complications, performing stitches, applying bandages, and more 3. Role of preparing the operating room, instruments and equipment for the procedure, with emphasis on maintaining a sterile environment, before, during and after the procedure 4. Development of manuals for orthopedic and neurosurgical procedures 5. Communicating with patient’s family before, during and after the surgery. Go over consent forms, answer questions about the procedure, do preoperative assessments. May update family members on the surgery status during the operation 6. Responsibility for the management of arthroscopic surgical equipment. Inventory management, usage training, and management strategy development of implant inserted during arthroscopic surgery. 7. As a circulating nurse, provided support in non-sterile areas to prevent contamination of sterile areas during surgery. Appropriately supplied sterilized products necessary during the surgical process. 8. Oversighting a surgery process, and controlling unexpected situation Show less