Ewa Lato

Ewa Lato

CRA, Altiora
Warszawa, mazowieckie

Umiejętności

Clinical Research Associates CRFs Microsoft Word Good Clinical Practice Driving License (B) Regulatory Compliance Clinical Trials Monitoring

Języki

polski
ojczysty
angielski
biegły
niemiecki
dobry
rosyjski
podstawowy

Doświadczenie zawodowe

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CRA
Altiora
Monitoring Visits & Reports, CRF & Source Data Verification, Initiation of Sites, Feasibility, Monitoring Pre-Study, Handover Process, Study Transfer, SAE Reporting, CA/EC Applications & Approvals, Initial Submissions, Regulatory Requirements & Correspondence, Trial Protocols, Laboratory Manuals, Contract Negotiations, Study Documentation, ISF, Patient’s Recruitment, Contacts with Investigators, Sites Trainings, Biosimilar Trials, Good Clinical Practice, Ethics in Clinical Research,
Microsoft Office, Interpersonal & Communication Skills

Projekty

MabionCD20-001RA
Rheumatology – Rheumatoid Arthritis, phase III, study MabionCD20-001RA (CRA, CTA)
Zakres obowiązków
Monitoring Visits & Reports, CRF & Source Data Verification, Initiation of Sites, Feasibility, Monitoring Pre-Study, Handover Process, Study Transfer, SAE Reporting, CA/EC Applications & Approvals, Initial Submissions, Regulatory Requirements & Correspondence, Trial Protocols, Laboratory Manuals, Contract Negotiations, Study Documentation, ISF, Patient’s Recruitment, Contacts with Investigators, Sites Trainings,

Szkolenia i kursy

British Council
Certificate in Advanced English
Goethe Institut
Zertifikat Deutsch als Fremdsprache

Edukacja

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Clinical Research Methodology, studia podyplomowe
Akademia Medyczna w Warszawie
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Biology, magisterskie
Uniwersytet Jagielloński w Krakowie

Specjalizacje

Badania i rozwój
Farmaceutyka/Biotechnologia