Wanda Batorska
Study coordinator of Clinical Trials, Wojewódzkie Centrum Onkologii Gdańsk
Szczebrzeszyn,
lubelskie
Umiejętności
• Driving license cat. B
• Computer literacy (Microsoft Office Tools)
• Business correspondence skills
• Experience in chairing meetings and making presentations
Języki
angielski
dobry
hiszpański
podstawowy
rosyjski
podstawowy
Doświadczenie zawodowe
Study coordinator of Clinical Trials
Wojewódzkie Centrum Onkologii Gdańsk
• site management of clinical trials (phase I-IV)
• arrangement, organization and supporting of all types of visits: evaluation, initiation, monitoring, close-out
• co-operation and correspondence with Sponsor representatives
• keeping study documentation at investigational site
• management of site start-up process
• preparing site to several audits, taking part in audit process
• supporting Principal Investigator in correspondence with Ethics Committee
• preparing documentary for clinical trials
• keeping electronic data base
• collecting, preparing and keeping biological samples
• co-operation with local and central laboratories (Covance, Quintiles, PPD, ICON)
• order, receive study drug supply and non-drug supply, stock control, tracking of expire dates, ensuring appropriate receipt and full accountability
• Interactive Voice Response Systems operation (ALMAC, ICOPHONE, IMPALA, RAMOS)
• Co-operation in independent radiology review vendors
• participation in Investigators Meetings
• medical conferences organization
• taking part in e-Learnings, Webex training sessions
• coordination of return and destruction of unused clinical supply
• organization of archiving study documentation after site close-out
• arrangement, organization and supporting of all types of visits: evaluation, initiation, monitoring, close-out
• co-operation and correspondence with Sponsor representatives
• keeping study documentation at investigational site
• management of site start-up process
• preparing site to several audits, taking part in audit process
• supporting Principal Investigator in correspondence with Ethics Committee
• preparing documentary for clinical trials
• keeping electronic data base
• collecting, preparing and keeping biological samples
• co-operation with local and central laboratories (Covance, Quintiles, PPD, ICON)
• order, receive study drug supply and non-drug supply, stock control, tracking of expire dates, ensuring appropriate receipt and full accountability
• Interactive Voice Response Systems operation (ALMAC, ICOPHONE, IMPALA, RAMOS)
• Co-operation in independent radiology review vendors
• participation in Investigators Meetings
• medical conferences organization
• taking part in e-Learnings, Webex training sessions
• coordination of return and destruction of unused clinical supply
• organization of archiving study documentation after site close-out
Study coordinator of Clinical Trials
Klinika Onkologii i Radioterapii , Gdański Uniwersytet Medyczny, Gdańsk
• site management of clinical trials (phase I-IV)
• training and coaching of new employed study coordinators
• arrangement, organization and supporting of all types of visits: evaluation, initiation, monitoring, close-out
• co-operation and correspondence with Sponsor representatives
• keeping study documentation at investigational site
• management of site start-up process
• preparing site to several audits, taking part in audit process
• supporting Principal Investigator in correspondence with Ethics Committee
• preparing documentary for clinical trials
• keeping electronic data base
• collecting, preparing and keeping biological samples
• co-operation with local and central laboratories
• order, receive study drug supply and non-drug supply, stock control, tracking of expire dates, ensuring appropriate receipt and full accountability
• Interactive Voice Response Systems operation
• Co-operation with independent radiology review vendors
• participation in Investigators Meetings
• medical conferences organization
• taking part in e-Learnings, Webex training sessions
• coordination of return and destruction of unused clinical supply
• organization of archiving study documentation after site close-out
• training and coaching of new employed study coordinators
• arrangement, organization and supporting of all types of visits: evaluation, initiation, monitoring, close-out
• co-operation and correspondence with Sponsor representatives
• keeping study documentation at investigational site
• management of site start-up process
• preparing site to several audits, taking part in audit process
• supporting Principal Investigator in correspondence with Ethics Committee
• preparing documentary for clinical trials
• keeping electronic data base
• collecting, preparing and keeping biological samples
• co-operation with local and central laboratories
• order, receive study drug supply and non-drug supply, stock control, tracking of expire dates, ensuring appropriate receipt and full accountability
• Interactive Voice Response Systems operation
• Co-operation with independent radiology review vendors
• participation in Investigators Meetings
• medical conferences organization
• taking part in e-Learnings, Webex training sessions
• coordination of return and destruction of unused clinical supply
• organization of archiving study documentation after site close-out
Szkolenia i kursy
2010 IATA Course - certificate
2007 GCP Course – certificate
2004 Urzad Rejestracji Produktow Leczniczych, Wyrobow Medycznych i Produktow
Biobojczych - New European Regulations in Clinical Trials
2007 GCP Course – certificate
2004 Urzad Rejestracji Produktow Leczniczych, Wyrobow Medycznych i Produktow
Biobojczych - New European Regulations in Clinical Trials
Edukacja
Specjalizacje
Administracja biurowa
Wprowadzanie/Przetwarzanie danych
Administracja biurowa
Zarządzanie biurem i administracja
Badania i rozwój
Farmaceutyka/Biotechnologia
Zainteresowania
• literature, trips organized with a group of friends, cycling, wall climbing