Kristy Pitts Email and Phone Number

• Provides operational guidance and oversight on over 35 clinical trials.• Directly supervises team of six clinical research coordinators• Participates in new hire processes• Develops onboarding workflows and orients new clinical research coordinators to the processes of the Structural Heart & Valve Center (SHVC).• Serves as intradepartmental liaison for SHVC research for various specialties across Emory Healthcare• Determines reportability of protocol deviations, adverse events, and UADEs to regulatory bodies• Completes Site Qualification surveys for incoming clinical trials as needed.• Coordinates investigational device purchasing agreements between clinical trial sponsors and Emory Healthcare. • Ensures proper invoicing to clinical trial sponsors• Assists with negotiations and execution of clinical trial budgets and contracts• Oversees research financial portfolio and rearranges efforts as needed.

• Served as Lead CRC on 20 different industry and NIH sponsored transcatheter-based device trials for treatment of valvular diseases. • Coordinated Compassionate and Emergent Use of investigational devices outside of the scope of actively enrolling clinical trials. • Responsible for training physicians, clinical support staff, and research staff on upcoming trials as well as protocol amendments. • Facilitated the startup of new clinical trials including: revision of reimbursement analysis, drafting/finalizing delegation of authority logs, and site initiation preparations. • Developed and implements center-wide CAPA plans as needed.• Reconciled budgetary discrepancies on various clinical trial grants.

• Trained new study personnel and organized new processes to aid in the functionality of the entire research staff.• Directly communicated with auditors during not-for-cause inspections conducted by both the FDA and Emory CTAC (Clinical Trial Audit & Compliance) Department

• Served as research staff on various industry sponsored transcatheter-based device trials for treatment for aortic, mitral, pulmonic and tricuspid valve diseases.• Experienced with subject approval and implants with Early Feasibility studies. • Enrolled patients in clinical trials via informed consent (ICF) processes • Administered various research assessments to patients including frailty, neurological examinations, MMSE, six-minute walks, and Quality of Life questionnaires.• Identified and reported adverse events extracted from patient medical records into various electronic databases. Reviewed adverse events with PI. • Maintained subject charts for continual monitoring by study sponsors.