The Regional Study Coordinator II 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 II 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 II ensures the three ways communication with the regional Diagnostic Client in their specific area of the word, the PM Global Study Manager appointed to the Pharma Sponsor and the regional laboratory operations testing site.
The Regional Study Coordinator II acts as consultant/Technical Expert in providing recommendations/advice to all parties, a-day-to-day project management oversight by managing, planning and coordinating all projects related as well as maintaining study documentation in accordance with customer expectations and in compliance with regulatory requirements.
Accountable of the proper and timely delivery of all the regional study related aspects and deliverables from win study notice to the closure of the study by working in close collaboration with the PM Global Study Manager and the Diagnostic Global Study Managers
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
Prepare, coordinate set up and 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 and lead 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
Ensures that all customer expectations are documented and acted upon in compliance with regulatory requirements
Serve as back up to Client Coordinator Specialists and Regional Study Coordinators
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
Medical Technology (MT) degree or Bachelor’s Degree or Equivalent Experience
University degree(BS) in ascientific field is a strong plus
Professional certification (ASCP,PMP or other) in area(s) expertise
3 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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