上海市,山东省-济南市,浙江省-温州市 | 若干人
• 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
• Education
Undergraduate degree or its international equivalent in clinical, science, or health‐related field from an accredited institution; a licensed health‐care professional (i.e., registered nurse); or equivalent work experience required
• Experience
2 to 4 years of local trial experience; exposure to MNC and global trials
• Preferred Education and/or Experience
Clinical research experience
Knowledge of ICH and local regulatory authority regulations regarding drug
An advanced degree (e.g., M.S.,M.B.A., PharmD, etc.)