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.
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.
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
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
ASSISTANT DIRECTOR, PROJECT MANAGEMENT AND NETWORK OPERATIONS
Erin Monari, Ph.D., CCRP
Manager, PROJECT MANAGEMENT OFFICE
Shannon Alford, M.PH., C.C.R.P.
Research Project Managers
IIT PROJECT MANAGER and clinical data analyst
Alex Mueller, M.S.
research project specialist
Abigail Masterson, M.S.
IIT Project Manager
Teresa Ware, M.P.H.
IIT PROJECT MANAGER
Priya Gurjar, M.A.
The Project Management Office can be contacted via email@example.com or via our PMO Manager, Shannon Alford, M.P.H., CCRP at 352-294-8146 or firstname.lastname@example.org.