Seo Hyun Choi

• Experience in global studies - As CRC of Professor Dr.Jung Yeon Shim, I have gained experience in all aspects of clinical research, including the Phase 3 global studies mentioned below.

"A Multicentre, Randomized, Double-Blind, Parallel-Group Placebo-Controlled, Phase 3, Efficacy and Safety Study of Tezepelumab in 5 to

"Phase III, randomized, observer-blind, placebo-controlled, multi-center, multinational study to evaluate the efficacy, immunogenicity, and safety of a Respiratory Syncytial Virus vaccine in infants and toddlers (PEARL)"

1) Pre-initiation work experience:
- Reviewed the Research Fund Management Plan to ensure that the research would be conducted according to an appropriate budget, and was also in charge of approving the final versin to the IRB.
- Pre-training related to clinical trials: I reviewed the protocol before the initiation meeting, and also received and stored supplies. I also completed related pre-training. (Labcorp-E-Learning Certificate, ERT-Clario Curriculum, EOA Certificate, Longboat-Protocol essentials, ICH GCP, Severe Uncontrolled Asthma and Tezepelumab Overview Certificate, IATA Certificate, Clinical Trial Coordinator CRC Newcomer Course Certificate, GCP Certificate, Imedidata-EDC Lab Data Handling Certificate)

2) Work experience during clinical trial:
- Initiation Meeting: I was in charge of the scheduling/arranging the meeting date and location, and asked protocol-related questions to ensure smooth progress of the clinical study.
- Subject Registration: I was in charge of coordinating the screening schedule after reviewing the EMR to see if the subject met the inclusion/exclusion criteria. I obtained the signature of caregiver/patient's ICF consent form, provided copy, and binded the original to the ISF.

-AE/SAE observation and reporting: At each visit, I checked whether the subject had any adverse reactions and recorded them in the EMR and eCRF. I educated the caregivers in advance to contact me immediately if an adverse reaction occurred so that they could contact me right away when they had symptoms or visited the emergency room. For example, when a subject visited the emergency room with an AE, I coordinated with the professor and CRA to report it immediately so that an SAE could be reported within 24 hours. In addition, according to the CTCAE, I recorded the adverse reaction name, start date and end date, severity, IP relevance, and measures taken in the EMR and eCRF. I was also in charge of submitting an SAE correction report to the IRB when the SAE name was modified.

-Sample Management and Delivery: In this study, there were samples that were sent to the Central Lab on the day of sample collection and samples that were stored as backups. Accordingly, I checked whether the backup samples were stored at the specified temperature and was also responsible for delivering them according to the protocol standards. I was responsible for tasks such as scheduling DHL and writing requisition forms in compliance with all delivery conditions according to the lab manual.

-eCRF and query resolution: I was in charge of eCRF based on the source documents written within 2 days of the visit date for each subject visit. If a query occurred, I answered if I could resolve it myself, and in case of an ambiguous issue, I reported it to the CRA or professor and answered the query according to their opinions.

- I was also in charge of document management tasks such as binding, and commercial invoice processing, and etc.

-IRB: I was in chare of submission of research fund management plan, submission of interim report, review of change contract, submission of SAE change report, etc.

3) Work experience after completion of clinical trial
- I was responsible for tasks such as file inspection, confirmation and return of items, and transfer of documents during the completion visit.