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Clinical Trial Associate - Plymouth Meeting

Summary of essential job functions

  • Set-up and maintain Trial Master File (TMF) including project documentation files, investigator files, study books, and project databases on more complex projects.
  • Assist in the preparation of informational documents and communications for designated projects, including internal and external correspondence.
  •  Work with Clinical Project Manager to collect relevant study information on timelines, progress and resources.
  • Implements and maintains project processes and tracking systems. Generates and distribute status reports to management and other clinical team members.
  • Coordinate and supports clinical team, consultant and vendor meetings. Assesses meeting requirements and plan appropriately (e.g., arrange meeting room, schedules teleconference, distributes meeting agenda, prepares and distributes meeting minutes, etc.).
  • Complete assigned tasks in accordance with GCP, ICH guidelines and regulatory requirements for clinical trial management.
  • Work with Clinical Data Management on assigned projects
  • Assist in vendor and site audits as needed.
  • Plan and participate in conduct of Investigator Meetings
  • Some travel may be required

Minimum Requirements

  • Bachelor's degree required, Master's degree preferred
  • Area(s) of expertise desired: Biology, Immunology, Bioengineering, Cell or Molecular Biology. Experience with vaccines highly preferred.
  • Years of experience required: Combination of 0-1 years of monitoring and/or 0 to1 years of clinical trial management experience.

Essential Requirements

  • Excellent oral and written communication skills, attention to detail and ability to interact effectively with management and prioritize diverse projects for multiple disciplines.
  • Working knowledge of FDA regulations/guidelines, ICH guidelines, and GCPs
  • Demonstrates an understanding of trial and protocol objectives

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer.

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