上海招聘

               Primary Function: 1)       Responsible for Quality control of clinical trials, including set up co-monitoring plan with project manager or designate personnel, conduct and report co-monitoring visit, follow-up issues identified during the co-monitoring visit. 2)       Assist project team on site selection / initiation / monitoring activities as CRA role when necessary. Major Responsibilities and Duties: 1)       Quality control: a)       Work on co-monitoring plan for project during the start-up phases together with project manager b)       Conduct and report co-monitoring visit according to co-monitoring plan or flexible when necessary c)       Discuss the issues identified during the co-monitoring visit with project manager or CRA’s line-manager d)       Assist the project manager or CRA’s line manager with site/CRA selection e)       Follow-op issues identified during the co-monitoring visit, share the findings and recommended action plan if applicable 2)       CRA role: a)       Act as the main line of communication between the sponsor and the investigator b)       Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout c)       Responsible for the safety and proper conduct throughout the trial d)       Verifying that the investigator follows the approved protocol and all GCP procedures e)       Verifying that source data/documents and other trial records are accurate, complete, and maintained f)        Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs Qualifications: 1)         Bachelor degree, or equivalent, in Medicine, Science or related discipline 2)         2+ year independent monitoring experience with Oncology or Phi study is preferred 3)         Strong knowledge in ICH-GCP 4)         Ability to review and evaluate clinical data 5)         Computer literacy desirable 6)         Professional use of the English language, both written and oral 7)         Excellence oral and written communication skills             

微信分享