We are seeking a Regional Study Coordinator I to support our diagnostic study group. This position will work onsite at our facility in Torrance.
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. Coordinates, plans, organizes and oversees, in his regional location, the completion of administrative and technical tasks during the Diagnostic 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. 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.
Duties will include the following:
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Act as ambassador on behalf of the Diagnostic client across Covance departments; exemplifies the concept of Signature Client Service through outstanding, personalized customer service skills.
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Provide information related to Dx studies in order to maintain accurate study tracker and workload activities information.
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Act as regional internal liaison to ensure proper and smooth communication between the Diagnostic Sponsor, the PM Global Study Manager, the Principal Investigators/Scientists, the laboratory operation and the various internal departments involved in the study ( Quality Assurance, Commercial Development, Global Laboratory Services Support, Specimen Storage, Data Management, Client Services, Information Technology) develop solutions, resolve issues and approve internal database loading/design plan
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Act as regional external liaison with assigned Diagnostic Client representatives (eg. Diagnostic CRA, Site Monitors, Study Managers) to ensure an outstanding and timely communication and deliverables
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Act as regional external liaison with assigned Diagnostic Client representatives (eg. Diagnostic CRA, Site Monitors, Study Managers) to ensure an outstanding and timely communication
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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
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Review the Diagnostic component of study Statement of Work to ensure local feasibility and make appropriate recommendations to the Study Design Lead in collaboration with the PM Global Study Manager and the DDS Global Study Manager
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Act as a remote regional liaison between Global Study Manager and the various internal departments involved in the study.
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Participate in Covance CLS development through continuous process improvement, quality and productivity
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Demonstrate through appropriate self-organization the ability to manage high administrative load
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Able to act efficiently in an environment with dynamic timelines and priorities
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Demonstrate strong interpersonal and communication skills that will build strong internal and external relationships to ensure deliverables are on time and within budget
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Prepare, organize and host CRA visits as needed.
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Participate into and prepare Client Audit related to Diagnostic studies
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Monitors study timelines and ensure proper coordination with the regional laboratory testing site, the CRA and all internal departments involved.
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Submit regulatory authority applications
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Manage external and internal meetings
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Track monthly Diagnostic services billable activities
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Report Adverse Events as needed to the global diagnostic Study Manager and Principal Investigator/Scientist
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Report protocol deviations as needed to the global diagnostic Study Manager and Principal Investigator/Scientist
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Serve as back up to Client Coordinator Specialist and Regional Study Coordinator II as needed
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Maintain all necessary study documentation, including but not limited to: study binders, material receipt forms, and material balance forms.
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Organize and Archiving study documentation and correspondence as requested by the client
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Filing and collating trial documentation and reports
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Perform physical inventory of study materials as needed
Experience Required:
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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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Associates degree of Medical Technology (MLT) or Bachelor’s Degree or Equivalent Experience
Preferred Experience:
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Computer literate
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Medical Technology (MT) degree or University degree(BS) in a scientific field is a strong plus.
Pay range: $60,000-$70,000
Labcorp is proud to be an Equal Opportunity Employer:
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