1996 - 2001 - Medical University in Bydgoszcz, Department of Pharmacy, Spec. Medical Analitic
TRAINING MEETINGS AND COURSES
Trainings 2006
Clinical Foundation Program - two weeks of monitoring training successfully finished with exam, provided by PPD in North Carolina, US
Trainings 2005
Pharmacovigilance in European Union: Train the Trainer, one week GCP training to prepare participants train investigators and monitors.
Drug advertisement: what is allowed
Quality Assurance in Clinical Trials: three modules: training provided by Monipol in Krak
New regulation in Clinical Trials after EU Merger
Trainings 2001-2003
Five trainings of professional sale technics
CURRENT POSITION
Clinical Research Associate : Global CRA, since May 2005
Asthma phase III study : pre-study visits and start-up, EC and Regulatory submission
Breast cancer phase II two studies. I performed initiation visits, monitoring visits and closeout, and Sponsor's audit
Benign prostatic hyperplasia phase III: pre-study visits, initiation, monitoring. Monitor at highest recruiting site (50 patients) and three others
Hyperlipidemia: phase III, monitoring visits - acute myeloid leukemia, phase III %96 pre study visits, initiation visits, 4 sites.
PREVIOUS POSITIONS
Safety and Quality Standards Specialist: Global Pharmaceutical Company, November 2003 - October 2005
Reporting clinical trials adverse events to headquarter, Ethics Committees and Regulatory Authorities, co-monitoring visits (epilepsy) with experienced monitors to learn monitors' job, GCP trainings for investigators during investigator meetings, GCP and safety training for CRAs, two internal audits (breast cancer and epilepsy).
Sales Representative : in Polish and US Pharmaceutical Companies, March 2001 - October 2003
OTHER PROFESSIONAL OCCUPATIONS
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PROFESSIONAL ORGANIZATIONS - SCIENTIFIC ASSOCIATIONS/SOCIETIES
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COMPUTER SKILLS
Windows 97, 98, XP,Microsoft Office, Acrobat Reader
LANGUAGE SKILLS
English - fluent
Russian - intermediate (good reading and understanding, poor speaking)
OTHER RELEVANT INFORMATION
Open for offers in Poland. Homer based or freelance