Winnie Ye Email and Phone Number

·         Document monitoring activities appropriately following ICH-GCP, local regulations  ·         Conduct monitoring (pre-study, initiation, routine monitoring and closeout visit)·         Ensure the quality and integrity of study delivery at trial sites, adherence to the study protocol, management plans, SOPs and applicable regulations·         Ensure that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)·         Manage site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution·         Provide protocol and related study training to assigned sites·         Facilitate clinical trial site contract and budget negotiation ·         Support Ethics Committee submission·         Ensure Investigator Site Files (ISF) in inspection-readiness status·         Ensure study documents in eTMF updated, maintained well and perform regular eTMF QC review per study requirement·         Perform co-monitoring visits ·         Support PM/APM in clinical trial management·         Conduct accompanied site visit·         Execute co-monitoring visit to assess ongoing CRA monitoring competency, identify issues and develop resolution strategies

·         Document monitoring activities appropriately following ICH-GCP, local regulations ·         Conduct monitoring (initiation, routine monitoring and closeout visit)·         Ensure the quality and integrity of study delivery at trial sites, adherence to the study protocol, management plans, SOPs and applicable regulations·         Ensure that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)·         Manage site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution·         Provide protocol and related study training to assigned sites·         Facilitate clinical trial site contract and budget negotiation ·         Support Ethics Committee submission·         Ensure Investigator Site Files (ISF) in inspection-readiness status·         Ensure study documents in eTMF updated, maintained well and perform regular eTMF QC review per study requirement·         Deliver data within timelines per required quality standard in accordance with monitoring requirement, applicable SOPs,ICH/GCP and local regulations·         Prepare documents for HGRAC application ;Associate PM to prepare the investigator meeting