Clinical Research Associate
vor 4 Monaten
Als **Clinical Research Associate** nehmen Sie bei der Umsetzung globaler klinischer Prüfungen unserer Arzneimittel und Medizinprodukte eine Schlüsselrolle ein. Neben Ihrem exzellenten Organisationstalent, Ihrer offenen Persönlichkeit und Flexibilität sind Ihr analytisches Denkvermögen, ausgezeichnete soziale Kompetenz und Überzeugungskraft gefragt.
- **Monitoring**: Sie führen on-site und remote Zentrumsinitiierungen, Monitoring
- und Close-out-Besuche von klinischen Prüfungen der Phasen I-IV durch. Sie sind verantwortlich für ein umfassendes und eigenständiges Management der Prüfzentren, inklusive Training und Motivation des Prüfpersonals.
- **Study Start**-Up: Sie führen Country
- und Site-Feasibilities in Abstimmung mit unserer medizinischen Abteilung durch und unterstützen bei der Auswahl der Prüfzentren. Sie sind verantwortlich für die Einreichung von klinischen Prüfungen in CTIS und die Beantwortung der Rückfragen.
- **Compliance**: Sie stellen sicher, dass in Ihren Projekten sämtliche interne und externe Vorgaben eingehalten werden und die Prüfzentren jederzeit inspektionsbereit sind. Sie überwachen kontinuierlich die ordnungsgemäße Durchführung der klinischen Prüfungen gemäß ICH-GCP-Richtlinien, gesetzlichen Bestimmungen, Prüfplan und Standard Operating Procedures (SOP). Dabei stellen Sie die Datenqualität und Einhaltung von Zeit
- und Zielvorgaben sicher.
- **Support**: Sie unterstützen das Team bei vielfältigen administrativen Aufgaben in-House.
- Master oder gleichwertiger Abschluss, idealerweise in einem gesundheitsbezogenen Studiengang (z. B. Medizin, Naturwissenschaft, Pharmazie) oder eine vergleichbare Ausbildung im Gesundheitswesen
- Idealerweise erste Monitoring-Erfahrung im Bereich klinischer Prüfungen der Phasen 1-4 sowie Kenntnisse der relevanten Vorschriften und Standards
- Ein hohes Maß an Flexibilität, Begeisterungsfähigkeit, Teamfähigkeit, Kommunikationsstärke und Belastbarkeit
- Freude an Reisetätigkeit (ca. 5 Tage/Monat)
- Ausgezeichnete Englischkenntnisse
- Sicherer Umgang mit MS Office
-
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