The Regional Study Coordinator I is responsible for the successful delivery of the study management activities related to diagnostic studies in their specific area of the world.
The Regional Study Coordinator I coordinates, plans, organizes and oversees, in his regional location, the completion of administrative and technical tasks during the Dx study life time in collaboration with the Principal Investigator, the regional laboratory testing site and the various internal departments involved in the deliverables of the study.
The Regional Study Coordinator I maintains a tight collaboration with the other study coordinators counter parts to align processes and production activities.
The Regional Study Coordinator I must show flexibility when appropriate and possesses capability to communicate globally to internal and external clients.
Principal Day-to-Day duties
Day-to-day local study related activities- including but not limited to: (80% of time in a single work week)
Prepare, organize and host CRA visits as needed.
Participate into and prepare Client Audit related to Diagnostic studies
Monitors study timelines and ensure proper coordination with the regional laboratory testing site, the CRA and all internal departments involved.
Submit regulatory authority applications
Manage external and internal meetings
Track monthly Diagnostic services billable activities
Report Adverse Events as needed to the global diagnostic Study Manager and Principal Investigator/Scientist
Report protocol deviations as needed to the global diagnostic Study Manager and Principal Investigator/Scientist
Serve as back up to Client Coordinator Specialist and Regional Study Coordinator II as needed
Regulatory/ Study Documentation duties-(20% 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.
Organize and Archiving study documentation and correspondence as requested by the client
Filing and collating trial documentation and reports
Perform physical inventory of study materials as needed
Associate of Medical Technology (MLT) degree or Bachelor’s Degree or Equivalent Experience
2 years of clinical laboratory experience or customer service experience, preferable in pharmaceutical industry. Experience with multidisciplinary lab background is a plus.
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