Clinical Research Associate
vor 3 Wochen
Als Clinical Research Associate (CRA) bei Biotronik sind Sie für die Organisation und Durchführung von Routine-Monitoring und Close-Out Visiten verantwortlich. Sie überwachen die ordnungsgemäße Durchführung der klinischen Prüfung gemäß ISO14155, ICH-GCP-Richtlinien, gesetzlichen Bestimmungen, Prüfplan und Standard Operating Procedures. Ihre Aufgaben umfassen auch die Überprüfung des Studienordners, die Sicherstellung der Datenqualität und Patientensicherheit sowie die Einhaltung von Zeit- und Zielvorgaben.
Ihre Aufgaben
Organisation und Durchführung von Routine-Monitoring und Close-Out Visiten
Kontinuierliche Überwachung der ordnungsgemäßen Durchführung der klinischen Prüfung gemäß ISO14155, ICH-GCP-Richtlinien, gesetzlichen Bestimmungen, Prüfplan und Standard Operating Procedures
Überprüfung des Studienordners
Sicherstellung der Datenqualität und Patientensicherheit sowie der Einhaltung von Zeit- und Zielvorgaben
Verfassen von Monitoring-Berichten, Follow-up Berichten
Ihr Profil
Ausbildung oder Studium im Gesundheitswesen, medizinisch-wissenschaftlicher Abschluss oder vergleichbare Ausbildung
Kenntnis des Medizinproduktemarktes und wissenschaftliches Verständnis
Erfahrung als Clinical Research Associate (CRA) oder Study Nurse
Sehr gute Kenntnisse der Regularien und gesetzlichen Anforderungen im Rahmen von klinischen Studien
Ausgezeichnete soziale Kompetenz, Flexibilität und Überzeugungskraft
Computerkenntnisse (MS Office) und Erfahrung im Umgang mit eCRFs, CTMS sowie eTMF
Englisch und Deutsch fließend in Wort und Schrift, jede andere Lanfessprache ist ein Plus
Reisebereitschaft (international)
Was wir bieten
Flexible Arbeitszeiten ohne Schicht- oder Teildienst. Bitte bewerben Sie sich online über unser Kandidatenmanagementsystem.
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