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 Project Management Office (PMO) at the UF Health Cancer Center offers a variety of services to promote successful Investigator Initiated Trials (IITs) from concept development to final result dissemination.
At the first inception of a cancer-related concept (which may range from a few sentences to a drafted protocol), UFHCC Cancer Center Members are requested to complete the IIT Project Management Services Request above. Once this request is received, a member of the PMO team will assist the investigator to guide the concept through the Investigator-Initiated Trial Concept Development Group “pre-review” process, which includes statistical, scientific, feasibility and budget reviews of the concept. The final result of this process is the completion of a fully-endorsed SRMC Pre-Review Approval Form. This review is mandatory for any IITs planning to utilize UFHCC Clinical Research Office (CRO) resources including 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, the PMO office may further support the project through help with applications for funding, protocol authoring and revising, FDA IND/IDE planning, tracking submissions and approvals through Feasibility Group, SRMC and IRB, eCRF creation, 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.
The PMO team is committed to engaging with investigators to develop innovative concepts, supporting ground-breaking research, and ensuring projects move as smoothly as possible through development to publication, in order to support the ultimate mission of the Cancer Center as a whole.
The Project Management Office can be contacted via its manager, Erin Monari, Ph.D., CCRC, at 352.273.8128 or firstname.lastname@example.org.