Covance Coordinator Specialist in Shanghai, China

Job Overview

The Coordinator Specialist is responsible for the completion and successful delivery of administrative tasks related to Diagnostic (Dx) and Companion Diagnostic studies , as assigned by the Global Study Manager , in their specific area of the world.

The Coordinator Specialist acts as a local liaison between DDS Study Managers, Study Coordinators and the various internal departments providing technical and administrative services for assigned studies. Must show flexibility when appropriate and possesses capability to communicate globally with internal and external clients

Principal Day-to-Day duties

Day-to-day local study related activities- including but not limited to: (75% of time in a single work week)

  • Maintain regulatory binders documentation

  • Preparation of regulatory authority applications

  • Physical inventory of study materials as necessary

  • Prepare, File, collate and send Dx study documentation and reportsto theDx client on time

  • Sendstudy documentation andmonitoringreportsto Dx clients

  • Prepare and coordinate local Dx clients visits

  • Support monthly billable activities as assigned.

  • Participate in internal and external meetings and take minutes

  • Serve as back up to Study Coordinator I as assigned

  • Ensures that all customer expectations are documented and acted upon in compliance with regulatory requirements

Regulatory/ Study Documentation duties-(25% of time in a single work week)

  • Maintain all necessary study documentation, including but not limited to: study binders, material receipt forms, and material balance forms.

  • Review Laboratory Raw Data binders’ prior Dx client visits.

  • Obtain, maintain and store Master Safety Data Sheet (MSDS)of the Dx reagents components

  • Organize andArchiving study documentation and correspondence as requested by the Dx client

Education/Qualifications

Minimum Required:

  • High School Diploma

  • Computer literate

  • English speakin-g and writing-Level Intermediate

Experience

Minimum Required:

1 year of clinical laboratory experience or customer service experience, preferable in pharmaceutical industry. Experience with multidisciplinary lab background is a plus.

or 3-4 years in an administrative support role or relevant experience within Clinical Operations.

Scientific background is preferred

Job Number 2018-23742

Job Category Other

Position Type Hidden (2052)

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