Savannah Perrotta
Associate Director Clinical Operations @Strata Oncology
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WORK HISTORY
Associate Director Clinical Operations @Strata Oncology
Oversee the execution of site-level risk assessments -Ensure monitoring plan compliance -Oversee site level protocol deviations, Action items related to CAPAs -Review and QC SOPs and clin ops processes -Oversee safety reporting -Assure TMF compliance -Assure clinical team training and onboarding -Communicate with all assigned sites through set calls, on-site visits and address ad hoc issues/inquires with sites-Present protocol information, specimen requirements and shipping information to sites -Manage CRO-led studies, including: manage study timelines and metrics; participate in selection and management/oversight of external vendors and develop vendor specifications; review vendor reports, budgets, and metrics; support study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel; prepare and present project debriefings, as required-Collaborate with major functional areas to identify and evaluate fundamental issues on the project, interprete data, making good business decisions and ensure the implementation of timely solutions -Ensure all project deliverables meet collaborator expectations as well as accurate forecasts -Work with the cross-functional team, the CPM develop study-related documentation; provide input for the design of the ICF template, CRFs, monitoring conventions, edit checks, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines, etc-Work with laboratory operations, plan the requirements for clinical trial material (aka laboratory kits) maintaining procedures to account for the CT material, and checking the expiration of CT material-Maintain study Trial Master Files -Train new CPMs -Other responsibilities as assigned.
EDUCATION
University of North Carolina Wilmington
Bachelors of Science, Human Biology
Cape Fear Community College
General Education Classes, College Transfer
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