Covance Coordinator Specialist in Shanghai, China
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
High School Diploma
English speakin-g and writing-Level Intermediate
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)
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.