Monitor is responsible to ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site in order to verify that:
The rights and well-being of human subjects are protected.
The reported trial data are accurate, complete, and verifiable from source documents.
The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement(s).
• Acting as the main line of communication between the sponsor and the investigator.
• Communicate with Japan Study Leader and third party vendors as needed.
• Conduct site selection activities for verifying adequate qualifications.
• Manage and monitor the responsible sites and ensure their quality appropriately, agreed cost spent and on a timely basis by conducting the followings;
Manage the contracts of clinical trial with the responsible site and ensure the compliance with regulations and company-wide governance controls such as Ethical Interactions policy or company-legal standard.
Input appropriate information in order to create clinical trial related documents (ex. CSP, IND).
Ensure a steady implementation of supplying clinical site with study materials.
Provide investigators and site staff with education and training regarding study specific procedures including EDC system.
Manage the patient recruitment status and request acceleration of patient recruitment for Investigators and site staff.
Conduct source data verification and ensure data quality to collect appropriate clinical study data.
If necessary, support sites to ensure sites understand and resolve data queries in a timely manner.
Ensure that essential documents and source data are appropriately stored in a clinical site.
Produce monitoring activity reports appropriately and in a timely manner.
Confirm and ensure status of GCP/ICH guidelines, CSP and AZ policy compliance.
Report critical and/or serious issues relating to site management to the study team and line manager in a timely manner.