Taipei, Taipei City, Taiwan
• Over 4 year of experience working at PPD as a Project Manager 6 year of experience working at PPD as a CRA • Over 1.5 years of experience working at ICON clinical research industry as a Clinical Trial Assistant As CRA, worked as both blinded and unblinded monitor on more than 10 Clinical trials in different Therapeutic areas: Genitourinary, Hematology/Oncology, and Infectious/Parasitic Diseases, unblinded monitor for oncology study. Gained significant experience in Chronic Kidney Disease, Breast cancer, and Lung cancer (NSCLC) as CRA. Experience in Clinical trials phases III-V, in adult population. Performed all types of Monitoring Visits: PSV, SIV, IMV and COV. Used different Clinical and client specific systems for trial management, such as EDC, CTMS, IVRS, IWRS, CTSP, Trial manager. Performed 100% or reduced SDV, on-site and remote visits. Familiar with AIM methodology and trained in Risk Based Monitoring. • Languages: English (verbal and written) Chinese (verbal and written)
• To provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s). •To contact candidates for the feasibility assignment •To assist CRA for doing the monitoring visit •To assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals. •To support the Clinical Operations teams with ongoing conduct of studies. •To be familiar with ICH GCP, appropriate regulations, relevant ICON SOP’s and ICON internal tracking systems. • To be familiar with the roles of the Clinical Research Associates (CRA) including site visits • To assist project teams with study specific documentation and guidelines as appropriate. • To set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival. • To process Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study. • To assist in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.). • To co-ordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate. • To assist project teams with trial progress tracking by updating the Clinical Trial Management systems. •To copy and route incoming correspondence, internal documentation, CRFs, etc., as appropriate. •To assist in co-ordination of Investigator payments, if applicable. • To assist in the tracking and distribution of safety reports. • To assist the Project Manager and project team with Investigator Meeting coordination, activities preparation and generate meeting minutes. • To assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations. • To assist with the coordination of team member tracking
Work with Project Leaders and Clinical Operation Leads to complete all tasks, such as enrolment figures and site personnel information data entry. • Regularly complete the Quarterly QC process and checklists to decrease the discrepancy between systems • Follow up with CRAs and COLs to update the monitoring assessment into systems. • Coordinate requests between study team and sponsor • Create Baseline Project Management Plan, which includes the communication Plan and link to Project Schedule • Prepare list of SOPs applicable to the project • Prepare draft Central Files Maintenance Plan, with input from PL and project team • Regular meeting with study team update the information into data management systems. • Provide Time code and upload data into Central File documents where applicable. Be responsible for Maintenance of Pfizer Clinical data system, Right Track II, for three studies. 1. Phase IV, global trial in FIBROMYALGIA 2. Phase IV, global trial in FIBROMYALGIA 3. Phase III, global trial in CARDIOVASCULAR 4. Phase II, global trial in NON-SMALL CELL LUNG CANCER