Ewelina Lenarczyk

• Execution of assigned clinical trials conducted in Poland
• Supervision of activities outsourced to CROs
• CRA Coaching
• Verifing MV reports
• Project management in Pulmonology, Neurology and Pediatric Trials
(start up process, ongoing phase)
• coordination of Investigator meeting
• support during site Audit

• Execution of assigned clinical trials conducted in Poland and Ukraine
• Supervision of activities outsourced to CROs (Quintiles, Parexel, ICON)
• Project management in Oncology (ongoing phase), Pediatric Urology (start up process) Trials
• coordination of Investigator meeting
• support during site Audit

• successful leadership and motivation of clinical project teams up to 10 people
• mentoring and training of Monitors

• Selection new sites on purpose of new clinical research trials, Identified and qualified potential investigators; Established new trials in chosen sites; Feasibility Process
• Preparation and submission Regulatory and EC clinical trial applications (including Financial Agreements and Budget Negotiation) according to standard and local country practices; Start-up process
• Site Initiation and Monitoring of Phase II-IV in Endocrinology (DM), Rheumatology, Gastroenterology, Urology, Oncology Trials
• EDC (electronic data capture) experience

• Management of depot for Investigational Product
• Worked closely with Medical Department: Clinical Research Associates, Clinical Trial Administrators and sites personnel (Investigators and/or Study Coordinator
• Controlled receiving medication phase II, III and IV from main center and sending to clinical sites
• Controlled terms and conditions of stocking medication in depot (temp., hum.)