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Clinical Research Coordinator 4 Lead

1 month ago


Charlottesville, Virginia, United States Commonwealth of Virginia Full time
Job Summary

The Department of Pediatrics at the University of Virginia's School of Medicine is seeking a Clinical Research Coordinator 4 Lead to join their dynamic research team. As a key member of the team, you will be responsible for overseeing clinical research efforts, managing multiple complex trials, and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Provide guidance and assistance to Principal Investigators on grant submissions, budget management, and research compliance oversight.
  • Assist Principal Investigators in developing clinical trial protocols and preparing and submitting required documentation to the Institutional Review Board, the University, federal regulators, and industry sponsors.
  • Coordinate and manage all aspects of clinical trial conduct for multiple ongoing clinical trials of varying complexity.
  • Participate in planning and analysis of research portfolios, in conjunction with department management and Principal Investigators.
  • Oversee the financial management of multiple clinical research projects, including budget development, billing reconciliation, and quarterly review of all Principal Investigator accounts.
  • Manage a team of Clinical Research Coordinators and/or laboratory or research support staff, with responsibilities including hiring, scheduling, workload management, compensation, rewards, professional development, and performance management.
  • Coordinate clinical research education, training, and/or orientation for new Faculty, Fellows, Residents, or medical students.
  • Develop administrative and financial recommendations for department management and Principal Investigators for research portfolio review.
  • Compile data and documents during internal and external audits and is ultimately responsible for the quality of submissions.
  • Participate in at least one research-related working group at the institutional level or lead a process improvement initiative at a department or division level.
  • Conduct research data analysis and literature searches. Co-author scientific papers, publications, or presentations.
Requirements
  • Education: Bachelor's Degree Required or equivalent combination of experience, education, and/or certifications.
  • Experience: At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work. Master's or other advanced degree may substitute for one year of clinical research experience.
  • Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire.