任职资格:
① >1 years experience as CRA
② Experience of phase I-IV trial, prefer oncology trial
③ Have monitoring experience from SSU to SC
④ Knowledge of ICH and local regulatory authority regulations regarding drug

工作职责:
? Implements and monitors local clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH‐GCP guidelines
? Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
? Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
? Provides regular site status information to team members, trial management, and updates trial management tool.
? Completes monitoring activity documents as required by Company or Sponsor SOPs or other contractual obligations
? Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
? Escalates site and trial related issues per Company SOPs, until identified issues are resolved or closed
? Performs essential document site file reconciliation
? Performs source document verification and query resolution
? Assesses IP accountability, dispensation, and compliance at the investigative sites
? Verifies Serious Adverse Event (SAE) reporting according to trial specifications and relevant local and ICH GCP guidelines
? Communicates with investigative sites
? Updates applicable tracking systems
? Ensures all required training is completed and documented
? Be assigned logistical support tasks by CTM for Investigator Meetings