高级临床监查员I [China]

 

职位描述：

• 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
• Implements and monitors local/global clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH‐GCP guidelines
• Manage the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial. Facilitates audit s and audit resolution
• 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
• Contribute to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.as directed by study management
• Perform additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc.) ensuring relevant training completed ahead of conducting additional or extended tasks
• May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines
• Serves as observation visit leader of CRA level 1 and 2
• May be assigned clinical tasks where advanced negotiating skills are required
• May be assigned training responsibilities with regards to coaching junior CRAs or supporting CTM at Investigator Meetings

任职资格：

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

• 4 years of local trial experience and/or minimum of 2 year of global trial experience
• Knowledge of ICH and local regulatory authority regulations regarding drug
• Experienced in CTMS, Etmf, EDC IVRS/IWRS system

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.)
• Experience in monitoring all trial components (PSSV to COV)
• Experience in coaching/mentoring other CRAs

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