Clinical Research Coordinator
vor 18 Stunden
Tätigkeiten
- Koordinative Aufgaben im Rahmen des Forschungsverbunds SPOG für das UKBB
- Unterstützung der Prüfärztinnen und -ärzte bei der Durchführung von klinischen Studien und wissenschaftlichen Projekten
- Organisation und Durchführung von Visiten der Studienpatient*innen
- Vorbereitung und Organisation von studienspezifischen Materialien und Proben einschließlich derer Versand
- Assistenz bei Protokoll-/GCP-konformer Durchführung von Studien
- Erfassung und Meldung von AEs, SAEs und SUSARs
- Erhebung und Dokumentation von Therapieverläufen und Follow-ups in CRFs mittels diverser Datenbanken sowie Aktualisierung und Archivierung von Studiendokumenten
- Vorbereitung und Begleitung von Monitoring-Visiten, Audits und Inspektionen
Anforderungen
- Erfahrung in der Durchführung und Organisation von klinischen Studien nach ICH-GCP und gültiges GCP-Zertifikat
- Abgeschlossene Ausbildung als Clinical Research Coordinator (CAS) oder als Pflegefachperson/Study Nurse oder Abschluss in einem medizinischen Assistenzberuf
- Forschungserfahrung in einem Team von Studienkoordinator*innen von Vorteil
- Begeisterung für die Thematik
- Ein hohes Maß an Qualitätsbewusstsein, Organisationsfähigkeit sowie eine selbständige und strukturierte Arbeitsweise
- Sehr gute Team- und Kommunikationsfähigkeit
- Fundierte Computerkenntnisse der gängigen MS-Office-Anwendungen und Datenbankprogramme
- Kenntnisse der medizinischen Terminologie
- Gute Deutsch- und Englischkenntnisse in Wort und Schrift
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