Cra Ssu - Experience In Regulatory And Monitoring - Mexico Home Based

CRA SSU - Experience in regulatory and monitoring - Mexico Home BasedJob ResponsibilitiesPerforms 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 Pharmacoepidemiological Practices (GPP) and protocol compliance.Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site‐specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops 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.Demonstrates diligence in protecting the confidentiality of each subject/patient.Assesses factors that might affect subjec...