Summer Guo Email and Phone Number

Mainly responsible for AP sites in 4 global trials during the start up period, Working closely with internal colleagues and external staffs(site staffs and vendors) to ensure the smooth process of clinical trials performed in AP countries and comply with the protocol, GCP and SOP. And 2 China only studies which focus on the vendor especially CRO management to ensure the quality and compliance for these outsourced trials.1. Site selectionAssist in designing questionnaire, collect information and estimate the feasibility of site to participate a study.2. Start up documents preparationCoordinator with vendors to prepare documents for EC submission.On country level, working with translation vendor to gain the various language versions of study documents. Ensure good quality and no deviation from the original ones.On site level, prepare the EC submission documents per site’s requirements. And make priority to catch up the nearly EC meeting.3. EC submissionMake and maintain relationship with site staffs, support EC meeting stuffs.Reply queries from EC, resolve issues happened in the submission, create site specific ICF if required, etc.4. Contract negotiationWork with project manager and payment team to create country level template.Negotiate with institution and internal staffs (Legal, finical department) till a final agreement is reached.5. On-going follow upFollow up on-going stage of the study. Especially when new information of the study is released. Handle the resubmission to EC.6. Vendor ManagementPerform interview to select suitable candidate.Provide protocol, GCP and company SOP training to CRO.Periodically hold the status review meeting to ensure the quality of the whole study.

1. Had monitoring experience in Immunology and Endocrinology study. And performed clinical monitoring activities of designated projects in accordance with the ICH/GCP and SOPs, which including: site initial, training site staff about the protocol’s procedure , collating regulatory documentation and IRB submissions, and monitoring activities (such as source data verification, drug accountability, etc. And also till the end of study activities such as documents collection, report submission. 2. Good communication with site staff, including negotiated of clinical trial agreements, patient recruitment related discussion, etc.3. Supported to resolve issues happened in the site, and focused on the quality of the study’s date and patient’s safety.

1. Supported to site manager and CRA teams in routine work. Such as preparing the EC submission binders, documenting the essential documents per ICH/GCP, delivering SUSAR reports to related site staff in required time.2. Maintained accurate study site information in the related system in a timely manner. Maintained daily tracker of essential documents, payment process and clinical trial agreements process.3. Assisted to arrange the investigator meeting.4. A specialist in system and site start-up