Project Management Office

From Concept to Care

The University of Florida Health Cancer Center Project Management Office (PMO) provides a variety of services to support and promote successful Investigator Initiated Trials (IITs) for UF Health Cancer Center members, from concept development to final result dissemination. By providing these services, the PMO plays a critical role in the startup and execution of IITs.

Mission Statement

The UF Health Cancer Center Project Management Office’s mission is to facilitate the conception, initiation and completion of high-quality investigator-initiated research by providing comprehensive management services, promoting positive collaborative partnerships, and supporting quality data collection and effective dissemination of results.

Program Aims

The PMO team is committed to engaging with investigators in order to support the ultimate mission of the UF Health Cancer Center via:

• Aiding in development of innovative concepts
• Increasing efficiency of research projects
• Providing administrative support from project development through publication

Process

At the first inception of a cancer-related concept (which may range from a few sentences to a protocol draft), the pre-review process consists of

• Step 1: Completing the IIT Project Management Services Request form.
• Step 2: Presenting the concept to the UFHCC IIT Think Tank (I2T3)  and incorporating feedback as appropriate.  PMO will assist with assigning the concept to a meeting and preparing materials for presentation. 
• Step 3: Obtaining a completed, fully endorsed I2T3 Concept Review Form with an approved study budget.

This process is mandatory for any cancer-relevant IITs categorized as interventional or otherwise involving investigational drugs, devices, or medical procedures planning to utilize UFHCC Clinical Research Office (CRO) resources inclusive of:

• Clinical Trial Management
• Clinical Research Coordination
• Data Entry Support
• Regulatory Management
• Financial or other in-kind support

Concepts not meeting these specifications may still request this service as a means to improve the feasibility, statistical, and scientific merit of the concept up-front, thereby potentially decreasing investigator effort in developing the protocol, as well as SRMC and IRB review timelines.

Once a concept has completed this pre-review process, PMO may further support the project through help with:

• Applications for funding
• Protocol authoring and revising
• FDA IND/IDE planning
• Tracking submissions and approvals through SRMC and IRB
• eCRF creation (in REDCap)
• Data management and exports
• Accrual monitoring
• Document version control
• Submission of reportable events to sponsors and other required bodies
• Activating external sites
• Leading study team meetings
• Attending internal regulatory oversight reviews
• And a variety of other protocol management or consultation services upon request

Our Team

Leadership

DIRECTOR, CLINICAL RESEARCH OFFICE

Erin Monari, Ph.D., CCRP

clh1230@ufl.edu

Manager, PROJECT MANAGEMENT OFFICE

Shannon Alford, M.PH., CCRP

salford@ufl.edu

Research Project Managers

IIT PROJECT MANAGER and clinical data analyst

Alex Leggett, M.S., CCRP

agmueller@ufl.edu

IIT Project Manager

Teresa Ware, M.P.H.

tware1997@ufl.edu

IIT PROJECT MANAGER

Priya Gurjar, M.A.

pgurjar@ufl.edu

IIT PROJECT MANAGER

Judy Walsh, B.A., CCRP

judywalsh@ufl.edu

Contact

The Project Management Office can be contacted via pmo@cancer.ufl.edu or via our PMO Manager, Shannon Alford, M.P.H., CCRP at 352-294-8146 or salford@ufl.edu.