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Clinical Trial Coordinator

PSI CRO

Clinical Trial Coordinator

Durham, NC +1 location
Full Time
Paid
  • Responsibilities

    Job Description

    This is an office-based position in King of Prussia, PA. 

    1. Site Management
    • Supervises and coordinates the exchange of data, documents and other project relevant information between investigative sites, the project team, the sponsor, and central / regional vendors
    • Coordinates the process of IRB/IEC and CA submissions and notifications
    • May coordinate financial and contractual tasks
    • Coordinates and assists with preparation and follow-up of site, and systems audits and inspections
    1. Other Communication
    • Exchanges data, documents, and other information with the project team, other departments, vendors and customers 
    • Coordinates and supervises communication within the project team
    • Coordinates and assists with organization of project meetings
    • Prepares draft agendas for, and minutes of, project meetings
    • Coordinates preparation, attendance and follow-up of Investigators´ Meetings
    1. Training
    • Conducts on-the-job coaching of Clinical Trial Administrators
    • Coordinates, conducts and monitors compliance of project-specific training of the study team members
    1. Document Management
    • Maintains Trial Master File (TMF)
    • Performs regular TMF QC for completeness and accuracy, and prepares TMF checklists
    • Assists in preparation and follow-up of TMF audits
    • Coordinates preparation, distribution, and update of Onsite Study Files (OSF) and OSF checklists
    • Supervises and coordinates translations
    1. Safety Management
    • Coordinates the safety information flow within the project team, and between the project team and investigative sites

     

    1. Compliance Monitoring
    • May perform IP-Release Enabling Document QCs
    • Participate in establishing and supervising in-process controls
    1. Project Management
    • May administratively coordinate clinical supplies (including medication) order, receipt, inventory store, distribution, return/recall and reconciliation
    • Assists with preparing draft newsletters, progress reports and project plans
    • Reviews, coordinates and maintains study-specific and corporate tracking systems
    • May be assigned other project management tasks
    1. Project Assignments

     

    • May be assigned a Project Coordinator role within a project
    1. Corporate/Departmental Assignments
    • Provides administrative assistance with feasibility research
    • May be involved in the development of practices and training initiatives related to project administration at a regional level
  • Qualifications

    Qualifications

    College or university degree or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities is considered sufficient.

    Minimum 12 months´ experience as a Senior Clinical Trial Administrator or a similar position in clinical research.

    Additional Information

    All your information will be kept confidential according to EEO guidelines.

  • Locations
    Durham, NC • King of Prussia, PA