11 set - Italia
Syneos
DescriptionCRA - Future Roles (Japan)Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®.WORK HERE MATTERS EVERYWHEREWhy Syneos HealthWe are passionate about developing our people, through career development and progression; technical and therapeutic area training;
We are committed to our Total Self culture – where you can authentically be yourself. We are continuously building the company we all want to work for and our customers want to work with. Job 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 Pharmacoepidemiology Practice (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 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. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site
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