Clinical Research Associate
Vor 2 Tagen
Unser Mandant aus dem Grossraum Schaffhausen sucht einen erfahrenen und motivierten **Clinical Research Associate (w/m/d)**, um dessen klinische Studien im Medtech-Bereich zu überwachen und zu unterstützen. Die Position ist dabei verantwortlich für die Überwachung von Studien, um sicherzustellen, dass sie den Anforderungen von CPM, GCP sowie ISO 14155 entsprechen.
**Aufgabengebiet**
- Überwachen von klinischen Studien, um sicherzustellen, dass sie den Anforderungen von CPM, GCP und ISO 14155 entsprechen
- Überprüfung der Studiendokumentation, einschließlich Protokolle und Studienberichte
- Unterstützen Sie das CPM und das klinische Team
- Überwachung von Studien-Sites, um sicherzustellen, dass die Studiendurchführung gemäß den Protokollen und den Anforderungen von GCP und ISO 14155 durchgeführt wird
- Überwachung und Überprüfung von Studiendaten, um sicherzustellen, dass sie vollständig, genau und konsistent sind
- Überwachung und Überprüfung von unerwünschten Ereignissen und Sicherheitsauswertungen, um sicherzustellen, dass sie gemäß den Anforderungen von GCP und ISO 14155 berichtet werden
- Unterstützung des Studienleiters bei der Überwachung der Studienkosten und -zeitpläne
- Zusammenarbeit mit dem Studienleiter, dem Studiensponsor und den Studien-Sites, um sicherzustellen, dass die Studie erfolgreich durchgeführt wird
**Anforderungsprofil**
- Abgeschlossenes Studium in einem klinischen, medizinischen, wissenschaftlichen oder einem verwandten Fachgebiet
- Berufserfahrung als Clinical Research Associate oder Clinical Monitor in klinischen Studien
- Fundierte Kenntnisse von CPM, GCP und ISO 14155
- Erfahrung in der Überwachung von klinischen Studien im Medtech-Bereich
- Fähigkeit, komplexe klinische Studien und Protokolle zu verstehen
- Ausgezeichnete Kommunikations
- und Organisationsfähigkeiten
- Sehr gute Kenntnisse in MS Office
- Verhandlungssicheres Englisch in Wort und Schrift
**Vergütungspaket**
- Attraktives Vergütungsmodell
- flexible Arbeitszeiten und Home Office-Möglichkeiten
- Individuelle Mitarbeiterförderung und -Qualifizierung
- Herausfordernde und abwechslungsreiche Aufgaben in einem innovativem Medizintechnikunternehmen
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