Job Responsibilities

Performs site qualification, site initiation, interim monitoring, site management activities, 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, provide recommendations regarding site‑specific actions, immediately communicate/escalate serious issues to the project team, and develop action plans.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate, and demonstrates diligence in protecting the confidentiality of each subject/patient.
• Assesses factors that might affect subject/patient safety and clinical da...