临床监查员CRA

Key responsibilities
• 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
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.)