Job Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management and close‑out visits (performed on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Uses judgment and experience to evaluate overall performance of site and site staff and provide recommendations regarding site‑specific actions; immediately communicates or escalates serious issues to the project team and develops action plans.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies that the process of obtaining informed consent has been adequately performed and documented for each subject or patient as required/appropriate and demonstrates diligence in protecting the confidentiality of each subject or patient.
• Assesses factors that may affect subject or patient safety an...