Clinical Research Associate

vor 4 Wochen


Frankfurt am Main, Hessen, Deutschland Hox Life Science GmbH Vollzeit

Wir suchen für unser globales Pharmaunternehmen am Standort Frankfurt am Main einen engagierten Clinical Research Associate (m/w/d), der/die sowohl Aufgaben im Bereich der operativen Durchführung klinischer Studien übernimmt als auch im Clinical Project Management unterstützt. Diese Position bietet eine hervorragende Gelegenheit für ambitionierte Fachkräfte, die sich vom Clinical Research Associate zum Clinical Project Manager (m/w/d) weiterentwickeln möchten.

Die Rahmenbedingungen:

Standort: Frankfurt am Main

Unternehmen: Globales Pharmaunternehmen

Gehalt: € € brutto p.a.

Arbeitszeit: 39 Stunden/Woche

Homeoffice: 2 Tage/Woche (nach Einarbeitung)

Befristung: 1 Jahr (Verlängerung & Übernahme sehr wahrscheinlich)

Ihre Aufgaben:
  • Unterstützung bei der operativen Durchführung klinischer Studien - Durchführung von Machbarkeitsanalysen der Studienstandorte
  • Auswahl, Qualifizierung und Schulung externer Anbieter und klinischer Studienstandorte
  • Einreichung bei den Zulassungsbehörden und der Unabhängigen Ethikkommission (IEC/IRB)
  • Verwaltung und/oder Durchführung der Vor-Ort-Überwachung der klinischen Studienstandorte
  • Bereitstellung des Prüfpräparats und studienspezifischen Materials
  • Unterstützung bei der Vorbereitung und Überprüfung von Dokumenten - Erstellung studienspezifischer Dokumente, Geheimhaltungsvereinbarungen und klinischer Studienverträge
  • Überprüfung studienspezifischer Dokumente mit QC-Schwerpunkt
  • Dokumentenmanagement - Pflege der Trial Master File (TMF) / eTMF und Sicherstellung der Audit-/Inspektionsbereitschaft
  • Unterstützung bei der Koordination klinischer Studien - Unterstützung bei der Planung, Kontrolle und Einhaltung von Budget, Zeitplänen und Qualität
Ihr Qualifikationsprofil:
  • Erfahrung in der Koordination und Durchführung klinischer Studienaufgaben
  • Berufserfahrung als Clinical Research Associate
  • Fortgeschrittene Kenntnisse relevanter Vorschriften (z.B. ICH GCP, DIN EN ISO, EU CTR, MDR, FDA)
  • Fließendes Englisch für den geschäftlichen Gebrauch
  • Flexibilität und die Fähigkeit, verschiedene klinische Studien und Teams parallel zu unterstützen

Wenn Sie diese spannende Herausforderung annehmen und Ihre Karriere im Bereich der klinischen Forschung und Projektmanagement weiterentwickeln möchten, freuen Ich mich auf Ihre Bewerbung

Marie-Luise Reif

Bei HOX können Sie sicher sein, dass Ihr Lebenslauf verstanden und Sie als Individuum wahrgenommen werden. Mit der Kombination aus eigener Berufserfahrung im Life Science Bereich und umfassendem HR-Wissen können wir Ihnen ein kompetenter und vor allem ehrlicher Partner in der Erreichung Ihrer beruflichen Ziele sein.

Bereitgestellt in Kooperation mit der Bundesagentur für Arbeit.



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