Wanda Batorska

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

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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
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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

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

Edukacja

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Administration, magisterskie
University of Gdansk
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Jurnalism and Public Relations, licencjackie
Gdańska Wyższa Szkoła Humanistyczna – Jurnalism and Public Relations

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