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Osaka-Shi, Osaka
Permanent
? Primary contact with investigative sites during study maintenance and -when assigned-, site start-up activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within the timelines agreed with project management and Site Readiness team. ? Develop awareness of regulatory legislation, guidance and practice in the assigned countries with the support from senior staff. Essential
5/23/2023 10:02:28 AM
Osaka, Tokyo
Assures the implementation of project plans for the clients as assigned at the client office, where you will be dispatched 1) Documenting and tracking study activities using relevant forms and tools, as well as relevant Project Management System with guidance/support 2) Assist in the preparation of study site specific materials in accordance with relevant SOPs 3) Assist with minute taking and documentation for sponsor/external or internal teleconferences as requested 4) Assist in setting up and m
5/23/2023 10:02:27 AM
? Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site Readiness team and that documentation meets the specifications required by applicable regulations and sponsor. ? Proactively interacts with EC/IRB/Third bo
Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with venders; and other duties, as assigned - Responsible for all aspects of site management as prescribed in the project plans - General on-Site Monitoring Responsibilities: - Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients
5/23/2023 10:02:23 AM