Regulatory Compliance

Kelly Tooley, BS, MEd

• Institutional Review Boards ( HSIRB, CYIRB, and the VA): organization of materials and coordination of activities for research projects.
• Establish Standard Operating Procedures and Practices to ensure the rights and privacy of human research participants and the security of their health information.
• Implements a comprehensive safety program.
• Maintains operations in accordance with the Food and Drug Administration (FDA) programs such as Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and the Clinical Laboratory Improvement Amendments (CLIA).

Core Analytical Laboratory Manager

Robin DiFrancesco, BS MT ASCP, MBA

• Plan, facilitate, track, and coordinate the activities the laboratory performs for the granting agencies, project investigators and sponsors of laboratory services
• Coordinates personnel, projects long range goals and designs laboratory operations based on overall knowledge of ongoing status of activities, performance, and output
• Research current technologies, publications, resources to continually update and improve the quality of laboratory operations
• Function as a liaison to project investigators, sponsors, clinical sites, and other groups outside the PRC CAL.
• Provide technical reports for sponsors and manuscript preparation
• Directs quality assurance and quality control program

Core Laboratory Management Committee

Jill Hochreiter, BS MT ASCP, Laboratory Supervisor

Qing Ma , Ph.D., Research Scientist

Robin DiFrancesco, BS MT ASCP, MBA

• Prioritize, plan, and implement project administrative and scientific activities within the core laboratory
• Delegate workloads and resources to technical personnel and students activities
• Supervise activities of technical personnel and students
• Track progress of projects and present results and/or issues to director
• Discuss and resolve
• Prepare reports, publications, and presentations of final data

Pharmacometrics Group

Alan Forrest Pharm.D., Director

• Contribute to planning study parameters and design to ensure that outcomes will be measurable and appropriate
• Review ongoing study outcomes to determine feasibility of analyses and upgrade study measures
• Mentor students and advise PRC faculty in performing study outcome analyses
• Design and perform outcome analyses for biometric measures

Information Technology and Data Management Core

Francesco Lliguicota, BS, Senior Programmer and IT Coordinator

Michael Richardson, IT Assistant

• Facilitate PRC faculty’s research website and database creation
• Participate in planning and administration of PRC research projects contributing IT solutions and services
• Program and update all PRC website operations
• Maintain servers and files