Alina Fenske
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Alina Fenske
- Current 12 years and 3 months, since Mar 2014
Clinical Research Associate
Unternehmen möchte nicht genannt werden
Investigational Site Managment (Site Initiation, On-Site Monitoring, Site Termination), EC submission (SRP), clinical core documents preparation (ICF, ISF, TMF)
- 5 months, Apr 2013 - Aug 2013
Research Operation Assistant
PAREXEL International GmbH
- reviewing & preparing of informed consent forms & e-CRFs - quality assurance of central & investigator site files - checking submission approval package & confidentiality agreement & contract site agreement & site payments for completeness & consistency - conducting country specific ICH-GCP training for COLs & CRAs - fulfilling operational tasks within study team communication & ensuring data quality & timeframe compliance - following-up audit findings & updating clinical trial specific data bases
- 1 year and 1 month, Feb 2012 - Feb 2013
Clinical Supply Support
PAREXEL International GmbH
- temperature monitoring for shipments& operational tasks within Clinical Trial Material (CTM) - arranging return process including trouble shooting, internal customer & vendor communication & maintenance of drug return database - initiating CTM destruction process & document preparation - supporting Interactive Voice Response System based on Investigational Medical Product consignment release process
Ausbildung von Alina Fenske
- 3 years, Mar 2011 - Feb 2014
Science
University of Wales
Clinical Monitoring Drugs and Drug Development Data Management Biostatistics Physiology Biochemistry Bioethics Guidelines & Laws for Clinical Research Evidenced based Therapeutics and Drug Development Project Managment
University of Wales
Sprachen
German
C2 (Verhandlungssicher / Muttersprachlich)
English
C1 (Fließend)
French
A1-A2 (Grundkenntnisse)
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