Syneos FSP COS 临床试验助理（合同)

SUMMARY
The position is responsible for providing clerical, administrative, and technical administrative support to one or more business units or clients within Clinical Operations.
JOB RESPONSIBILITIES
• 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
QUALIFICATION REQUIREMENTS (please indicate if ‘preferred’)
• Bachelor degree or above
• Good communication and interpersonal skills
• Ability to embrace new technologies
• Minimal travel up to 25% may be required