Doświadczenie zawodowe
właściciel, Freelance CRA
- preselection of sites
- IEC submission
- assistance in CA submission
- contract negotiating
- initiation visits preparing
- full monitoring
- evaluation visits
- closeout visits
- IEC submission
- assistance in CA submission
- contract negotiating
- initiation visits preparing
- full monitoring
- evaluation visits
- closeout visits
Clinical Research Associate (CRA)
- preselection of sites
- initiation visits
- evaluation visits
- full monitoring
- closeout visits
- initiation visits
- evaluation visits
- full monitoring
- closeout visits
Szkolenia i kursy
2002 - GCP Training
2002 - CRA introduction training
2003 - International Clinical Operations meeting
2005 - Prestudy Visit Training
2005 - Intralinks administrator training
2005 - CTMS training
2006 - SDE (Secure Document Exchange), Data Review
Alignment, SUSAR Reporting training
2006 - Business Development, New Drug Development
Process, GSPs, 21CRF part 11, Quality Assurance,
Regulatory Affairs and Medical Writing, Drug
Safety and SAEs, Data Management training.
2006 - Pharmacoviligance EU
2007 - Good Clinical Practice for Clinical Development
2007 – Remote Data Capture
2008 – Polish and EU law and regulations in Clinical
Trials organized by Informedia 11-12 March 2008,
Warsaw
2008 – Remote data Capture and CTMS systems
2002 - CRA introduction training
2003 - International Clinical Operations meeting
2005 - Prestudy Visit Training
2005 - Intralinks administrator training
2005 - CTMS training
2006 - SDE (Secure Document Exchange), Data Review
Alignment, SUSAR Reporting training
2006 - Business Development, New Drug Development
Process, GSPs, 21CRF part 11, Quality Assurance,
Regulatory Affairs and Medical Writing, Drug
Safety and SAEs, Data Management training.
2006 - Pharmacoviligance EU
2007 - Good Clinical Practice for Clinical Development
2007 – Remote Data Capture
2008 – Polish and EU law and regulations in Clinical
Trials organized by Informedia 11-12 March 2008,
Warsaw
2008 – Remote data Capture and CTMS systems
Edukacja
Specjalizacje
IT - Rozwój oprogramowania
Zarządzanie projektem
Inne
2001 - Scholarship of Polish – American Liberty Foundation
and Health Care Mangers Society
and Health Care Mangers Society
Grupy
Uniwersytet Warszawski
Uniwersytet Warszawski, założony w 1816 roku, jest największą polską
uczelnią i jednocześnie jedną z najlepszych w kraju.
Clinical Research & badania medyczne
Grupa dla wszystkich badaczy, lekarzy, naukowców i ludzi biznesu związanych pośrednio i bezpośrednio z medycyną
Pharma Market
Grupa dla osób związanych z rynkiem farmaceutycznym. Wymiana informacji, nowości w branży oraz informacji z rynku. Nowości firmy DOCS International. Osoby z ukrytym profilem nie będą akceptowan