工作职责:
61 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
61 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
61 Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
61 Provides regular site status information to team members, trial management, and updates trial management tool.
61 Completes monitoring activity documents as required by Company or Sponsor SOPs or other contractual obligations
61 Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
61 Escalates site and trial related issues per Company SOPs, until identified issues are resolved or closed
61 Performs essential document site file reconciliation
61 Performs source document verification and query resolution
61 Assesses IP accountability, dispensation, and compliance at the investigative sites
61 Verifies Serious Adverse Event (SAE) reporting according to trial specifications and relevant local and ICH GCP guidelines
61 Communicates with investigative sites
61 Updates applicable tracking systems
61 Ensures all required training is completed and documented
61 Be assigned logistical support tasks by CTM for Investigator Meetings
任职资格:
1. About 2 years of local trial experience; exposure to MNC and global or Local Phase I -IV trials Clinical research experience
2. Knowledge of ICH and local regulatory authority regulations regarding drug
3. An advanced degree (e.g., M.S., M.B.A., Phar.D., etc.)