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Clinical Research Associate

vor 2 Monaten


Berlin, Berlin, Deutschland Una Health Vollzeit
Beschreibung der Position

Wir suchen eine/n Clinical Research Associate (w/m/d) zur Unterstützung unseres Teams auf Freelance-Basis in Bayern, NRW oder Hessen, mit Reisetätigkeit zu den Studienzentren. Das Projekt ist befristet bis September 2025.

Aufgaben und Verantwortlichkeiten
  • Überwachung und Management von Studienzentren, Sicherstellung der Einhaltung von Studienprotokollen, GCP und regulatorischen Anforderungen.
  • Durchführung von Site Initiation Visits (SIV), Interim Monitoring Visits (IMV) und Close-Out Visits (COV)
  • Durchführung der Source Data Verification (SDV) und Sicherstellung einer genauen Datenerfassung und Dokumentation
  • Laufende Unterstützung der Studienzentren, Management von Anfragen und Sicherstellung einer zeitnahen Problemlösung
  • Unterstützung bei der Schulung des Studienpersonals in Studienprotokollen und der Ausfüllung von CRFs
  • Vorbereitung und Einreichung von Monitoring-Besuchsberichten und anderen studienbezogenen Dokumentationen
Qualifikationen und Erfahrungen
  • Abschluss in Life Sciences, Medizin oder einem verwandten Bereich.
  • GCP-Zertifizierung (Good Clinical Practice).
  • Mindestens 5 Jahre Erfahrung als CRA (vorzugsweise in der Diabetologie und/oder digitalen Gesundheitsbereich)
  • Nachweisliche Erfahrung im Management klinischer Studien von der Initiierung bis zum Abschluss.
Weniger ist mehr

Wir suchen nach einer/n Person, die:

  • Starke Motivation hat, die digitale Gesundheit voranzutreiben und einen Beitrag zu innovativer klinischer Forschung zu leisten.
  • Hervorragende organisatorische und kommunikative Fähigkeiten besitzt.
  • Fähig ist, selbstständig zu arbeiten und das Zeitmanagement effektiv zu gestalten.