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Syneos FSP 外資 Global Pharma

? Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions

? Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines

? Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits

? Prepares and maintains site manuals, reference tools and other documents

? Maintains, updates, and inputs clinical tracking information into databases

? Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client

? Manages shared mailbox, processes site requests and routes correspondence appropriately

? Coordinates the ordering, packaging, shipping and tracking of site supplies and materials

? Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items

? May handle receipt, tracking and disposition of Case Report Forms and Queries

? Maintains overall awareness in the field of clinical research by completing all necessary and assigned training



Qualifications

? High School diploma or equivalent

? Good communication and interpersonal skills

? Ability to embrace new technologies

? Minimal travel up to 25% may be required