Work closely with Director and Ass. Director of Clinical Trials Section to facilitate the ongoing management of foundation, donor, federal, association or other funded research projects to insure timely study report generation for appropriate groups ie. Study sponsors, DSMB’s, Project Officers, Boards for quarterly, annual or final study reporting. Assist the Director’s, Principal Investigators and the Clinical Research Manager to determine targets for federally funded applications and assist with application submissions; establishing timelines, coordinating fiscal, regulatory and operational activities. Responsible for working with study staff to develop protocol materials, consents, study timelines and manuals of operations for submitted and funded grants.
Collaborate with all collaborative groups (Faculty, OneFlorida, Individual Divisions, WARRIOR). Ensure that the study documents are properly organized, and work with study staff to manage study data. Provide Clinical Trials Performance metrics weekly for internal review and monthly for Study PI’s and Division Chief and Administrator. Work with external sites to facilitate project development across study sites for WARRIOR and with OneFlorida projects. Travel to new clinic sites across Florida, Georgia as needed to assist with site operational activities Serve as the communication hub for collaborative efforts to make sure that grant progress and updates are disseminated to all appropriate groups.
Responsible for REDCap development and management for investigator initiated projects. Perform data analytics for key trial metrics to generate compliance metrics to insure fidelity of study data. Report data to PI’s, study coordinators and other appropriate groups as warranted.
Serve as a contact person for potential research participants for research projects for Regenerative Medicine Center. Review eligibility and recruitment material; provide and explain enrollment information to potential participants.