临床监查员 - Chengdu
2周前
Job summary
The Clinical Monitor performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist ensuring that the trial is conducted in accordance with the approved protocol ICH-GCP guidelines applicable regulations SOPs guaranteeing subjects rights well-being data reliability Ensures audit readiness develops collaborative relationships with investigational sites detailed tasks responsibilities assigned to role are outlined in task matrix Monitors investigator sites risk-based monitoring approach applies root cause analysis critical thinking problem-solving skills identify site processes failure corrective/preventive actions bring site into compliance decrease risks ensures data accuracy SDR SDV CRF review on-site remote monitoring activities Assess investigational product physical inventory records review Documents observations reports letters timely manner using approved business writing standards Escalates observed deficiencies issues clinical management expeditiously follow issues resolution May need maintain regular contact between monitoring visits investigative sites confirm protocol followed previously identified issues resolved data recorded timely manner conducts monitoring tasks accordance approved monitoring plan Participates investigator payment process ensures shared responsibility project team members issues/findings resolution Investigates follows-up findings applicable Participates investigator meetings identifies potential investigators collaboration client company ensure acceptability qualified investigative sites Initiates clinical trial sites relevant procedures ensure compliance protocol regulatory ICH GCP obligations making recommendations warranted Performs trial close out retrieval trial materials Ensures required essential documents complete place according ICH-GCP applicable regulations Conduits on-site file reviews per project specifications Provides trial status tracking progress update reports Clinical Team Manager CTM as required Ensures study systems updated agreed study conventions e.g Clinical Trial Management System Facilitates effective communication investigative sites client company PPD project team written oral electronic contacts Responds company client regulatory requirements/audits/inspections Maintains completes administrative tasks expense reports timesheets timely manner Contributes project team assisting preparation project publications/tools sharing ideas/suggestions team members Contributes other project work initiatives process improvement require职位描述
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