成都-临床监查员

到岗时间：不限 年龄要求：不限 性别要求：不限 婚况要求：不限 工作职责:1）Act as the main contact between sponsor an d investigator site staffs;2） Propose the potential investigational sites to project leader for a specific study. Verify thequality of the investigator an d the suitability of the sites by performing study feasibility Ｏr siteevaluation visit if necessary to ensure the site is qualifled an d suitable to conduct the study.Provide site evaluation report to project leader;3） Ensure the smooth negotiation process on the site contract sign-o仔. Be responsible for sitepayment is properly paid according to the agreement;4） Be involved in the preparation of the documentation for submission to EC;5） Ensure the study is performed only after the EC approval is obtained;6） perform initiation, regular monitoring an d close out visit to investigator site in compliancewith study monitoring plan, company SOP, local regulations an d ICH-GCP on budget andtimeline. Prepare an d submit accurate an d timely site visit reports for all performed visits;7） Manage study activities at assigned investigational sites. Discuss any issue identified andsupport the study sties staff as required;8） Ensure that Investigators are aware of their responsibilities an d the need to comply withcompany procedures, local regulations an d ICH GCP;9） Keep close follow-up on subject enrollment an d protocol compliance at site to ensure theenrollment speed is aligned with planned an d study implementation at site is in compliancewith SOP, relative regulations an d ICH GCP;10） Document an d archive all clinical trial relevant activities;11） Keep an d maintenance the ISF an d TMF to ensure it is Ｕpdate, complete an d accurateaccording to SOP an d ICH-GCP.12） Verify the accuracy, completeness an d legibility of the data collected in the studies;13） Ensure all case report forms can be collected an d queries can be resolved in a timelymanner;14） Verify the trial supply is stored, transferred, an d tracked appropriately. an d unusedInvestigational product an d other study supplies is returned Ｏr destroyed at site properlyafter the completion of study.15） Provide regular study Ｕpdates to the project leader an d Ｕpdate tracking tools utilized asappropriate.16）participate in project team meetings an d provides feedback an d suggestions for asuccessful completion of the project.17） Prepare an d participate investigator meeting as directed by the project leader.18） Assist in the preparation for the internal Ｏr external audit/inspection. Resolve issues cited inaudit reports.19） To take on any other task as assigned by line-manager/project leader任职资格:Bachelors degree & above, clinical medicine would be preferred2 years experience in clinical research execution as an CRA is preferredStrong people communication skillFluent in English speaking, reading an d writing.Good organization an d coordination skillGood presentation skillGood time management skillGood problem solving skills an d initiativesAttention to detailGood computer skill