Nouveau Roche

Sr Clinical Research Associate - CPS

  • Shanghai (中华人民共和国)
  • Marketing

Description de l'offre

  Job facts

You will be responsible for:

·  Responsible for the management of designated sites in clinical trial including:
·  Site assessment
·  Preparation of the monitoring plan and execution in compliance with visit frequency and all assigned tasks throughout the study.
·  Planning and Execution of Study Logistics Plan, including eventual delegation of activities to Support Group
·  Safety and proper conduct throughout the trial
·  Site specific data management
·  Mentoring and coaching new CRAs
·  Running studies mostly independently
·  Contributing country specific aspects in the development of protocol, protocol revisions, amendments and CRF design.

You should have:

·  Bio-medical related scientific degree; can vary from a bachelor, master and nursing qualifications.
·  More than 3 years of experience as CRA, 2-5 years of Clinical laboratory experience
·  Knowledge of applicable standards an regulations for clinical trials and lab conduct (International Conference on Harmonization / WHO Good Clinical Practice standards (ICH-GCP), IVD directives, FDA regulations
·  Practical experience in study monitoring according to global standards (ICH)
·  Ability to work in local and global study teams, incl virtual teams, cultural awareness

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