Sinior Clinical Research Associate

• Aug 2020 - Present

Clinical Research Associate

• Jun 2019 - Aug 2020

• Complete Site Start-up Unit for assigned oncology clinical trails. • Managing multiple clinical studies and sites to assure accurate and timely initiation, enrollment, conduct and completion for assigned clinical trials.• Quality management of the site appropriately per SOP, Serving as liaison to study sites and the sponsor. • Partner and co-monitoring with external CROs.• Data management activities of the subjects including verification and review of adverse events, serious… • Complete Site Start-up Unit for assigned oncology clinical trails. • Managing multiple clinical studies and sites to assure accurate and timely initiation, enrollment, conduct and completion for assigned clinical trials.• Quality management of the site appropriately per SOP, Serving as liaison to study sites and the sponsor. • Partner and co-monitoring with external CROs.• Data management activities of the subjects including verification and review of adverse events, serious adverse events to confirm accurate data reporting in accordance with the protocol;• Closeout visits for sites in compliance and maintain effective working relationships with investigator and query resolution follow-up.• Training entry level CRAs by providing leadership, protocol and monitoring support as well as moderate level procedures, guidelines, standards and GCP regulations knowledge sharing. Show more Show less

CRA

• Sep 2017 - Jun 2019

• Complete SSV and Agreement, EC submission, site initiation, monitoring, CO-visit, DBL and site close-down in accordance with company requirements and SOPs.• Project ethical review follow-up and submission, assist in completing the application of HGR changing request.• Site investigator’s relationship management and maintenance and negative issues prevention through performing on-going and monitoring site visits on a routine basis.

CRA

• Oct 2016 - Sep 2017

• Engage in clinical trial management on a day to day level such as participate in project discussions and• Complete training for site investigators.• Support the work related to site GCP-organization and EC • Assist in the completion of clinical trial specimen shipment in accordance with SOP, as well as cell production shipment• Compile and maintain clinical trial document and data reports, CRF files retrieve, etc.