Job Summary:

Project Coordinator works alongside project managers and is the liaison for document management, issue management and project reporting. This is a ‘hands-on’ role that will be responsible for ongoing operational support for existing projects as well as supporting new project implementations. The Project Coordinator will use templates, standard processes and guidelines.

Major Responsibilities:

  • Coordinate meetings, create meeting minutes, manage and update project materials, and keep project team updated
  • Work with the project managers to understand specific sponsor/client issues
  • To coordinate clinical research study records, maintain study files and help report physician payments per PPSA (Physician Payment Sunshine Act)
  • Prepare solution administration, user guides and system training documentation
  • Work with development, support and quality assurance resources
  • Facilitate the completion of IRB initial applications, continuing reviews and required regulatory documents
  • Perform project management duties to support the completion of the study
  • Help resolve project conflicts
  • Address issues from Quality Assurance reviews
  • Support studies by preparing & shipping regulatory binders & additional patient materials to sites
  • Have the ability to create, manage, and maintain a database of sites, their requirements, shipping records etc.
  • Coordinate with Project Managers and the Office Manager to ensure that studies are well stocked with necessary supplies
  • Assist in project related event planning, which may include off-site duties (investigator meetings, etc.)
  • Responsible for maintaining TMF
  • Manage Study Supply inventory (shipping supplies to sites, tracking inventory, ordering additional supplies as needed under the project manager’s supervision)
  • Complete any other ancillary tasks assigned by the company from time to time
  • Assisting project managers where needed with recruitment initiatives and tracking
  • Complete Pre-Qualification Visits as needed for projects

Qualifications:

  • BA/BS degree in relevant field required
  • 3+ years of experience performing project coordination in a related environment
  • Strong competency with MS Office Suite
  • Must be able to perform well with minimal direction in a highly-dynamic, timeline-driven environment
  • Must also be highly organized, detail-oriented and customer-focused with the ability to manage multiple priorities
  • Willing and able to travel (40%)

To apply, please send a copy of your resume/cover letter to pqueen@totalcro.com with Project Coordinator as the subject