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Study Startup Coordinator

PSI CRO

Study Startup Coordinator

Durham, NC +1 location
Full Time
Paid
  • Responsibilities

    Job Description

    • Monitors startup key performance indicators for selected projects on regional/country level
    • Identifies and escalates operational issues to Project Management and other functions concerned
    • Cooperates with other functions to conduct training and work on process improvement pertaining to study and site startup
    • Partakes in the development and update of local instructions and guidelines related to startup activities
    • Provides startup support for selected projects - starting from handover to Operations until all sites are activated
    • Participates in regional kick-off meetings/calls
    • Provides support and technical assistance in feasibility and site identification process
    • Coordinates and supports contract negotiation process 
    • Coordinates and supports preparation of IP-RED packages
    • Performs training of team members tailored to project needs
  • Qualifications

    Qualifications

    • College or University degree or an equivalent combination of education and experience that provides the individual with the required knowledge, skills, and abilities
    • Minimum of 18 months industry experience in clinical research in an administrative role
    • Excellent knowledge of FDA guidelines and ICH GCP
    • Communication and interpersonal skills
    • Attention to detail
    • Ability to work in a team or independently

    Additional Information

    If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. You will lead dedicated startup teams and work closely with cross-functional experts to drive your startup projects forward.

  • Locations
    Durham, NC • King of Prussia, PA