Since March 2008,I have been working in the Immuno Assay Department of CapitalBio Corporation. As the current head of clinical trial team, I have following responsibilities and accomplishments: (1)R&D: Develop CLIA (ChemiLuminescent ImmunoAssay) reagent kits for clinical use.Implemented T3, T4, FT3, FT4, CA19-9 and CA15-3 assay projects independently and successfully; (2)Clinical Trial: Organized clinical trial test and documentation projects for 20 assays including T3… Show more Since March 2008,I have been working in the Immuno Assay Department of CapitalBio Corporation. As the current head of clinical trial team, I have following responsibilities and accomplishments: (1)R&D: Develop CLIA (ChemiLuminescent ImmunoAssay) reagent kits for clinical use.Implemented T3, T4, FT3, FT4, CA19-9 and CA15-3 assay projects independently and successfully; (2)Clinical Trial: Organized clinical trial test and documentation projects for 20 assays including T3, T4, T3, FT4, TSH, TGAb、TPOAb、C-P, INS, CEA, CA125, CA15-3, CA19-9, PSA, F-PSA, AFP, FSH, LH, PRL and T-HCG. All 20 assays have been certificated by Chinese FDA successfully. Ongoing projects cover various kinds of tumor markers and hormones. (3)Integration with instrument (automatic immunoanalyzer) development: Maintain the link between the instrument and reagent development; facilitate the communication between the instrument and reagent team; coordinate the test combined with reagent kits and the instrument. (4)Internal & External Training: Supervise appropriate training of the technical transfer from the R&D team to production department and quality management department.Organize external large-scale training to potential customers on exhibitions or to current clients in hospitals, with both theoretic knowledge and hands-on practice. (5)External links: Responsible for communication with the organizations outside the company, including the Food and Drug Administration, related hospitals and joint ventures so as to facilitate the cooperation. (6)Administration: Project management and meeting organizing. Assist the department director on other administation work as required. Show less