Christina Rude (née Fehér)

- Line management of ClinOps staff (incl. admin oversight, professional development, appraisals, counselling, assignment of project work [ensuring projects are suitably resourced etc] - Participation in interview process & new hire on boarding - Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) & compliance with federal and local guidelines & ICH GCPs - Conduct of sign off & assessment visits - Organizes & chairs clinical staff meetings

Lead CRA: - Responsible team member clinical/site managing study deliverables as functional Lead CRA - Evaluate and reports direct report workload forecast and trends - Attends and presents monitoring/site management status during sponsor meetings - Routinely review CTMS, CRF, TMF, Drug Management - Review content and quality of monitoring documentation - Line Management responsibility for staff member (since Feb2017)

Lead CRA: - Responsible team member clinical/site managing study deliverables as functional Lead CRA - Evaluate and reports direct report workload forecast and trends - Attends and presents monitoring/site management status during sponsor meetings - Routinely review CTMS, CRF, TMF, Drug Management - Review content and quality of monitoring documentation - Line Management responsibility for staff member (since Feb2017)

Senior CRA: - Monitoring (PSSV, SIV, RMV, COV) - Reporting and tracking (study deliverables) - Data Management (analytical thinking) - IP Management (inventory, reconciliation) - Record keeping (ISF and TMF) - Training or mentorship on junior CRAs