From Concept to Care
The University of Florida Health Cancer Center (UFHCC) Project Management Office (PMO) provides a variety of services to support and promote successful Investigator Initiated Trials (IITs) for UFHCC members, from concept development to final result dissemination. By providing these services, 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 startup process consists of:
- Step 1: Completing the IIT Project Management Services Request form.
- Step 2: PMO assisting through Investigator-Initiated Trial Concept Development Group (CDG) pre-review (statistical, scientific, feasibility and budget reviews).
- Step 3: Having a completed fully endorsed SRMC Pre-Review Approval Form
This review is mandatory for any cancer-relevant IITs categorized as “interventional treatment” or otherwise involving investigational drugs, devices, or medical procedures planning to utilize UFHCC Clinical Research Office (CRO) resources consisting 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
- 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
ASSISTANT DIRECTOR, PROJECT MANAGEMENT AND NETWORK OPERATIONS
Erin Monari, Ph.D., CCRP
clh1230@ufl.edu
Manager, PROJECT MANAGEMENT OFFICE
Shannon Alford, MPH, CCRP
salford@ufl.edu
Research Project Managers
IIT PROJECT MANAGER and clinical data analyst
Alexandra Mueller, M.S.
agmueller@ufl.edu
IIT PROJEct manager
Abigail Masterson, M.S.
amasterson@ufl.edu
IIT Project Manager
Teresa Ware, MPH
tware1997@ufl.edu
Contact
The Project Management Office can be contacted via pmo@cancer.ufl.edu or via our PMO Manager, Shannon Alford, MPH, CCRP at 352.294.8146 or salford@ufl.edu.