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Study Star-up and Maintenance Prepare for, plan, organise and conduct site initiation visits and investigator meetings with the Project Manager Assist in the preparation of ethics committee submissions Motivate and train investigators and ensure that the study site personnel have a good understanding of the protocol, the investigational product and the requirements of the study and that they can fulfil their obligations to conduct the study accurately and to deadlines Site management responsibilities, including but not limited to: o Remote and some on-site monitoring of trial progress and implement strategies as required to ensure adherence to the study protocol, study procedure manual, SOPs, ICH/GCP and other applicable ethical guidelines o Assist participating site personnel in the local management of the study where required o Ensure serious adverse events and medical events of interest are appropriately documented and reported according to the study protocol and applicable regulatory and ethical requirements o Organise and manage the trial files, including in-house and site trial files, to ensure they are appropriately filed, managed and stored o Detect and report protocol deviations and implement corrective measures as required Create and review monitoring visit and progress reports accurately and within the predetermined timeframe and send to the project manager Create and review site activation check list and essential documents with the project manager Regularly update project tracking tools and systems Coordinate, track and process invoices for study payments to investigational sites and vendors, accurately and in a timely manner Study Execution and Closure Site management Conduct on site and remote monitoring of participating centres to ensure: o Quality, accuracy, completion, and timeliness of data entry..
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