Clin Ops Specialist | Taiwan
Syneos Health
Taiwan
4天前

JOB SUMMARY

The position is responsible for providing clerical,administrative, and technical administrative support to one or more businessunits or clients within Clinical Operations.

JOB RESPONSIBILITIES

  • Responsible for performing activities in compliance withapplicable Corporate and Clinical Operations Policies, Standard OperatingProcedures and Work Instructions
  • Assists Clinical Monitoring staff with site managementactivities, including serving as a Sponsor representative for sites on assignedstudies, and communicating with sites to ensure compliance with protocolrequirements, 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 andother documents
  • Maintains, updates, and inputs clinical tracking informationinto databases
  • Tracks incoming and outgoing clinical and regulatorydocuments and updates for investigator sites, studies, project team, or client
  • Manages shared mailbox, processes site requests and routescorrespondence appropriately
  • Coordinates the ordering, packaging, shipping and tracking ofsite supplies and materials
  • Assists with coordination of team meetings, attends meetingsand prepares accurate meeting minutes and action items
  • May handle receipt, tracking and disposition of Case ReportForms and Queries
  • Maintains overall awareness in the field of clinical researchby completing all necessary and assigned training
  • Qualifications

    QUALIFICATION REQUIREMENTS

  • HighSchool diploma or equivalent
  • Goodcommunication and interpersonal skills
  • Abilityto embrace new technologies
  • Minimal travel up to 25% may berequired
  • Disclaimer :

    Tasks, duties, and responsibilities as listed in this jobdescription are not exhaustive. The Company, at its sole discretion and with noprior notice, may assign other tasks, duties, and job responsibilities.

    Equivalent experience, skills, and / or education will also be considered soqualifications of incumbents may differ from those listed in the JobDescription.

    The Company, at its sole discretion, will determine whatconstitutes as equivalent to the qualifications described above.

    Further,nothing contained herein should be construed to create an employment contract.Occasionally, required skills / experiences for jobs are expressed in briefterms.

    Any language contained herein is intended to fully comply with allobligations imposed by the legislation of each country in which it operates,including the implementation of the EU Equality Directive, in relation to therecruitment and employment of its employees.

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