Service Coordination Specialist

Laboratory Corporation of America Holdings (Covance)

Durham, North Carolina, United States of America

Job Summary:

Accountable for the execution and oversight for the delivery of all services within an FSP model, in line with the current Clinical Service Agreement (CSA).  Responsible to ensure high quality performance for optimal service delivery.  Responsible for providing instructions and direction on all tasks and activities related to the Covance unblinded CRAs (uCRAs) roles.  Primary point of contact (POC) for Covance uCRAs in case of issues with tasks assigned.  Primary POC for client Managers regarding unblinded monitoring services.  Works collaboratively with client managers for forecasting, planning and execution of all services, as per CSA.


Required:  Minimum of five (5) years relevant clinical research experience including demonstrated skills and competency in clinical project management tasks, especially regarding quality and metric management.  In lieu of the above requirements, candidates with > five (5) years supervisory experience in a heath care setting and five (5) years clinical research experience with at least one (l) year project management experience in the pharmaceutical or CRO industries will be considered.  Experience in managing projects in a virtual environment.  Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.  Financial awareness and ability to actively utilize financial tracking systems.  Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.  Demonstrated ability to lead by example and to encourage team members to seek solutions independently.  Excellent communication, planning and organizational skills.  Ability to review/analyze and report relevant data and interpret protocols and regulatory documents.  Ability to work independently.  Ability to negotiate and liaise with clients in a professional manner.  Ability to present to staff at all levels.  Strong computer skills with an ability to understand, access and leverage technology alternatives.  A working knowledge of ICH GCP, US FDA regulations, regulations applicable to local office, guidelines, and practices regarding Good Clinical Practices


University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.  In lieu of the above requirement, candidates with six (6) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.  Detailed knowledge of financial control procedures (i.e. costing systems, time reporting).  Working knowledge of project management processes.  Working knowledge of time and cost estimate development  Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries. Thorough understanding of the drug development process

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2022-04-29 00:00:00

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