Clinical Research Associate
vor 2 Wochen
Die Clinische Studien Gesellschaft (CSG) ist eine renommierte Full-Service Contract Research Organisation mit Sitz in Berlin. Unser Schwerpunkt liegt in der europaweiten Durchführung klinischer Studien und Beobachtungsstudien für Arzneimittel, Medizinprodukte und digitale Gesundheitsanwendungen in allen Indikationsgebieten. Als CRO der IGES Gruppe erschließen wir ein breites Spektrum von Real World Daten. Wir forschen im Auftrag unserer Kunden darüber hinaus auch zu den Themen Inanspruchnahme, Medical Need, Patientenpräferenzen und Clinical Pathways.
Zur Verstärkung unseres Teams im Bereich der klinischen Forschung suchen wir zum nächstmöglichen Zeitpunkt einen
Clinical Research Associate (CRA) / Klinischen Monitor (m/w/d)
Aufgaben
- Planung, Vorbereitung und Durchführung von Monitoringvisiten gemäß SOPs (sowohl onsite als auch remote)
- Fristgerechte Erstellung von Berichten und Follow-Up Dokumentationen der Monitoringvisiten
- Vorbereitung und Einreichung von Antragsunterlagen für Studienvorhaben bei Behörden und Ethikkommissionen
- Management und/oder Unterstützung von Studienzentren
- Sicherstellung der Validität der Studiendaten und Erstellen von Data Queries
- Teilnahme an Prüfarzttreffen sowie Planung und Durchführung studienspezifischer Trainings
Qualifikation
- Hochschulabschluss im medizinisch-technischen/medizinisch-dokumentarischen
oder naturwissenschaftlichen Bereich oder eine vergleichbare Ausbildung
- Erste Berufserfahrung in einem ähnlichen Feld, z. B. als Klinischer Monitor in einer CRO oder einem pharmazeutischen Unternehmen
- Profunde Kenntnisse der relevanten Regularien (ICH-GCP und AMG, MPG)
- Problemlösefähigkeit, exakte Arbeitsweise und gute analytische Fähigkeiten
- Ausgeprägte kommunikative und soziale Kompetenz
- Sehr gute Organisationsfähigkeit und Flexibilität
- Bereitschaft zur regelmäßigen Reisetätigkeit
- Gute Englischkenntnisse in Wort und Schrift
**Benefits**:
- Abwechslungsreiche und spannende Projekte
- Unbefristetes Arbeitsverhältnis und flache Hierarchien
- Ein angenehmes Arbeitsumfeld im Zentrum Berlins
- 30 Tage Urlaub sowie Heiligabend und Silvester frei
Wenn Sie diese Aufgabe reizt, freuen wir uns über Ihre aussagekräftigen Bewerbungsunterlagen (Anschreiben, Lebenslauf und Zeugnisse) unter Angabe Ihrer Gehaltsvorstellungen und des frühestmöglichen Eintrittstermins an Alina Weber. Für weiterführende Informationen steht Ihnen Frau Weber (030/230 809-418) gern zur Verfügung.
CSG - Clinische Studien Gesellschaft GmbH
Human Resources
Friedrichstraße 180
10117 Berlin
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