пропозиції роботи
Michał Szepke
Clinical Study Coordinator, Neurologiczny NZOZ, Centrum Leczenia SM, ul. Fabianowska 40, 62-064 Plewiska, Poland
Poznań,
wielkopolskie
Dołącz do GoldenLine i obejrzyj pełny profil tego użytkownika
Zobacz pełny profil
Umiejętności
Advanced Process Control
Clinical Research Experience
IVR
Microsoft Office
Planning & Organizing Skills
Teamworking Skills
znajomość zasad GCP
eCRF - Rave
Clinical Trials Management
Analiza danych - Data Analysis
Języki
polski
ojczysty
angielski
biegły
Doświadczenie zawodowe
Clinical Study Coordinator
Neurologiczny NZOZ, Centrum Leczenia SM, ul. Fabianowska 40, 62-064 Plewiska, Poland
Preparing all the documents needed to initiate the site within a clinical study (PSSV, SIV visits);
assisting the PI in the pre-screening and screening processes and potential baseline visit as a crucial point in the study;
study staff support with key study activities and maintain patients' safety;
participation in providing the sponsor with study data (study drug, adverse events, concomitant medications as well as patients' general wellbeeing);
taking care of good cooperation between the Sponsor, the PI and the CRO;
continous monitoring compliance of GCP rules.
assisting the PI in the pre-screening and screening processes and potential baseline visit as a crucial point in the study;
study staff support with key study activities and maintain patients' safety;
participation in providing the sponsor with study data (study drug, adverse events, concomitant medications as well as patients' general wellbeeing);
taking care of good cooperation between the Sponsor, the PI and the CRO;
continous monitoring compliance of GCP rules.
Clinical Study Coordinator, Investigational Product Administrator
Neurologiczny NZOZ, Centrum Leczenia SM, ul. Fabianowska 40, 62-064 Plewiska, Poland
Preparing all the documents needed to initiate the site within a clinical study (PSSV, SIV visits);
assisting the PI in the pre-screening and screening processes and potential baseline visit as a crucial point in the study;
study staff support with key study activities and maintain patients' safety;
participation in providing the sponsor with study data (study drug, adverse events, concomitant medications as well as patients' general wellbeeing);
taking care of good cooperation between the Sponsor, the PI and the CRO;
continous monitoring compliance of GCP rules,
receipt of investigational product shipments;
storage of study drug according to Sponsor's requirements;
reporting of temperature excursions;
asissting the Study Coordinator in the process of study drug assignment.
assisting the PI in the pre-screening and screening processes and potential baseline visit as a crucial point in the study;
study staff support with key study activities and maintain patients' safety;
participation in providing the sponsor with study data (study drug, adverse events, concomitant medications as well as patients' general wellbeeing);
taking care of good cooperation between the Sponsor, the PI and the CRO;
continous monitoring compliance of GCP rules,
receipt of investigational product shipments;
storage of study drug according to Sponsor's requirements;
reporting of temperature excursions;
asissting the Study Coordinator in the process of study drug assignment.
Clinical Study Coordinator, Investigational Product Administrator
Neurologiczny NZOZ, Centrum Leczenia SM, Os. Pogodne 22, 62-064 Plewiska, Poland
Preparing all the documents needed to initiate the site within a clinical study (PSSV, SIV visits);
assisting the PI in the pre-screening and screening processes and potential baseline visit as a crucial point in the study;
study staff support with key study activities and maintain patients' safety;
participation in providing the sponsor with study data (study drug, adverse events, concomitant medications as well as patients' general wellbeeing);
taking care of good cooperation between the Sponsor, the PI and the CRO;
continous monitoring compliance of GCP rules,
receipt of investigational product shipments;
storage of study drug according to Sponsor's requirements;
reporting of temperature excursions;
asissting the Study Coordinator in the process of study drug assignment.
assisting the PI in the pre-screening and screening processes and potential baseline visit as a crucial point in the study;
study staff support with key study activities and maintain patients' safety;
participation in providing the sponsor with study data (study drug, adverse events, concomitant medications as well as patients' general wellbeeing);
taking care of good cooperation between the Sponsor, the PI and the CRO;
continous monitoring compliance of GCP rules,
receipt of investigational product shipments;
storage of study drug according to Sponsor's requirements;
reporting of temperature excursions;
asissting the Study Coordinator in the process of study drug assignment.
Assistant Accountant
Checking of financial data provided by the business partners;
providing data for invoices clearing process;
providing data for invoices clearing process;
Clinical Trials Assistant
Szpital Wojewodzki w Poznaniu, ul. Juraszow7/19, 60-479 Poznan, Poland
Providing data for proper execution of study financial clearing;
assisting in preparation all the documents needed to initiate the site within a clinical study (PSSV, SIV visits);
assisting the PI in the pre-screening and screening processes;
participation in providing the sponsor with study data (study drug, adverse events, concomitant medications as well as patients' general wellbeeing);
taking care of continuous monitoring compliance of GCP rules.
assisting in preparation all the documents needed to initiate the site within a clinical study (PSSV, SIV visits);
assisting the PI in the pre-screening and screening processes;
participation in providing the sponsor with study data (study drug, adverse events, concomitant medications as well as patients' general wellbeeing);
taking care of continuous monitoring compliance of GCP rules.
Szkolenia i kursy
Investigator Site Personnel ICH GCP Training Certificate, TransCelerate Biopharma Inc., 04May2017;
A Review of ICH E6, Revision 2 Changes for Site Personnel Working on Clinical Research Studies (Version
date 01-FEBRUARY-2017), Inc Research, Certificate of Completion, 10Oct2017;
Rave Reporter, date of completion: April 2017;
EDC Essentials for Clinical Research Coordinators, date of completion: April 2017
A Review of ICH E6, Revision 2 Changes for Site Personnel Working on Clinical Research Studies (Version
date 01-FEBRUARY-2017), Inc Research, Certificate of Completion, 10Oct2017;
Rave Reporter, date of completion: April 2017;
EDC Essentials for Clinical Research Coordinators, date of completion: April 2017
Edukacja
Public Health, magisterskie
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
Management, inżynierskie
Politechnika Poznańska
Zainteresowania
Music;
Sport;
New Technologies
Sport;
New Technologies
Grupy
BioKariera
O studiach, pracy i karierze w naukach przyrodniczych i biomedycznych (biotech, biopharma, biomedicine & life sciences)
Clinical Research & badania medyczne
Grupa dla wszystkich badaczy, lekarzy, naukowców i ludzi biznesu związanych pośrednio i bezpośrednio z medycyną
