Clinical Research Associate

vor 1 Woche


Köln, Nordrhein-Westfalen, Deutschland Universitätsklinikum Bonn Vollzeit
Beschreibung

Wir suchen Sie für die Stelle des Clinical Research Associates / Projektmanns. als Teil unseres interdisziplinären Teams an der Universitätsklinikum Bonn.

Aufgaben und Pflichten
  • Klinisches Monitoring von klinischen Prüfungen verschiedener Indikationen nach CTR, AMG, MDR und MPG sowie biomedizinischer Forschungsvorhaben am UKB und deutschlandweit
  • Projektkoordination und Unterstützung des Projektmanagements bei der Planung und Durchführung von klinischen Studien verschiedener Indikationen der Phasen I-IV nach AMG und MPG sowie biomedizinischer Forschungsvorhaben und Beobachtungsstudien (eigeninitiiert) am UKB
  • Regulatorische Abwicklung (Vorbereitung der Einreichungsunterlagen), Koordination der beteiligten Parteien (Kontakt zu den Prüfzentren), Dokumentenerstellung im Rahmen der Vorbereitung und Durchführung klinischer Studien
  • Erstellung von Manualen, Einwilligungserklärungen, Risikoanalysen und Logs
Zuständigkeit und Verantwortung

Sie sind verantwortlich für das klinische Monitoring von klinischen Prüfungen in verschiedenen Indikationen und arbeiten eng mit unserem interdisziplinären Team zusammen. Ihre Aufgaben umfassen auch die Projektkoordination und die Unterstützung des Projektmanagements bei der Planung und Durchführung von klinischen Studien.

Qualifikationen und Erfahrungen
  • Abgeschlossene Ausbildung im Gesundheitswesen (Krankenschwester o.ä.) oder vergleichbare Ausbildung bzw. Studium
  • Abgeschlossene Weiterbildung zur Study Nurse von Vorteil
  • Weiterbildung zum Klinischen Monitor von Vorteil
  • Berufliche Vorerfahrung in der Betreuung und im Monitoring von klinischen Studien sowie Kenntnisse über GCP, AMG/CTR oder MPG/MDR
  • Sehr gute EDV-Kenntnisse (Microsoft Office (insbes. Word, Excel, PowerPoint), Internet, Erfahrung mit eCRF-Systemen oder Datenbanken o.ä.)
  • Ausgeprägte kommunikative Fähigkeiten, insbesondere in Zusammenarbeit mit den Verantwortlichen in den Kliniken, Instituten oder administrativen Bereichen
  • Fließende Deutschkenntnisse, sehr gute Englischkenntnisse (in Wort und Schrift)
  • Zuverlässigkeit, Verantwortungsbewusstsein und Genauigkeit
  • Reisebereitschaft bis zu 50 % der Arbeitszeit deutschlandweit im Rahmen des on-site Monitorings
  • Fähigkeit zu teamorientierter Arbeit
  • Selbstständigkeit, Flexibilität und Belastbarkeit sowie Eigeninitiative im Denken und Handeln
Löhne und Benefits

Der Gehaltsspiegel liegt zwischen €60.000,- und €80.000,- pro Jahr brutto, abhängig von Ihrer Qualifikation und Erfahrung. Darüber hinaus bieten wir Ihnen ein vielfältiges Paket an Benefits, einschließlich einer gesetzlichen Rentenversicherung, einer Unfallversicherung und einer Berufsunfähigkeitsversicherung.

Wir freuen uns darauf, Sie als Teil unseres interdisziplinären Teams an der Universitätsklinikum Bonn begrüßen zu dürfen.



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