Job Responsibilities

• Perform 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 Practices (GPP) and protocol compliance.
• Use judgment and experience to evaluate overall performance of site and site staff and provide recommendations regarding site‑specific actions; immediately communicate/escalate serious issues to the project team and develop action plans.
• Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verify that the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
• Demonstrate diligence in protecting the confidentiality of each subject/patient.
• Assess factors that might affect subject/patient’s safety and cli...