DFW Metroplex Residents Only

Assistant Project Manager  

The Assistant Project Manager supports clinical trial specific activities in accordance with Sponsor and CRO SOPs, ICH-GCP requirements, and FDA and local regulations. The Clinical Research Study Associate acts as liaison for all patient recruitment activities, involving extensive marketing through media sources, phone and email communication.

Major Responsibilities:

  • Assist in developing and implementing study-wide recruitment plans with goals and timelines, ensuring adherence to recruitment budget
  • Analyze issues and obstacles in recruitment to develop improved and new recruitment initiatives
  • Interact frequently with sites to support recruitment efforts
  • Generate recruitment reports weekly
  • 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, pre-qualification visits, etc.)
  • 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

Qualifications:

  • BA/BS degree in relevant field required
  • 3-5 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 (20%)
  • Ability to manage multiple, simultaneous projects
  • Excellent oral and written communication, organizational and planning skills
  • This is an in-office position based out of our Uptown Dallas office.
  • Only local residents will be considered