Clinical Research Associate 2

Vor 2 Tagen

Home Office, Schweiz ICON Vollzeit

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Die Rolle:
ICON arbeitet mit einem der erfolgreichsten globalen Biotechnologieunternehmen zusammen, um es bei der Entwicklung neuer Medikamente in kritischen Bereichen zu unterstützen, um die Gesundheit und Lebensqualität auf der ganzen Welt zu verbessern. Um dies zu erreichen, suchen wir derzeit einen Klinischen Monitor/Clinical Research Associate I-III (m/w/d) in Österreich im Homeoffice.

Zu den Hauptaufgaben gehören:
Planung von Studien
- Mitwirkung bei der Identifizierung neuer Standorte für klinische Studien; Analyse der Möglichkeiten und Unterstützung von CRMA und CSM bei der Abgabe von Empfehlungen für die Aufnahme von Studien.
- Übernahme einer Botschafterrolle zur Erleichterung der Kommunikation zwischen den Prüfzentren und dem Novartis CPO, um das Nutzenversprechen für die Prüfer zu erhöhen.
- Erleichterung der Vorbereitung und Sammlung von Dokumenten auf Standort
- und Länderebene während aller Phasen der Studie. Unterstützung des CSM bei der Beaufsichtigung der Country und Site Trial Master Files (TMF). Während aller Phasen der klinischen Prüfung stellt er die Archivierung gemäß den einschlägigen SOP sicher.

Studienstart
- Durchführung der Einweisung und Schulung des Prüfzentrums, Erstellung des Berichts über den Einführungsbesuch

Durchführung der Studie
- Durchführung des kompletten Standortmanagements einschließlich Überwachungsbesuchen, behördlicher Bewertung, Verwaltung der Arzneimittelversorgung usw., um die Einhaltung des Prüfplans, der GCP, der globalen und lokalen Vorschriften sowie der globalen und lokalen Prozesse sicherzustellen.
- Identifizierung von Problemen an den Standorten; Lösung von Problemen und gegebenenfalls Eskalation.
- Vollständige Vorbereitung und Erstellung von Besuchsüberwachungsberichten gemäß den einschlägigen SOP
- Überprüfung und Verwaltung der Daten vor Ort; Lösung technischer und inhaltlicher Probleme auf kontinuierlicher Basis, um die Ziele für die rechtzeitige Sperrung der Datenbank zu erreichen.
- Bei der Zusammenarbeit mit zentralen CRAs (verblindete und unverblindete) Reaktion auf Warnmeldungen und Nachverfolgung, um die Lösung von Problemen sicherzustellen

Abschluss der Studie
- Durchführung der Aktivitäten zum Abschluss der Studie und Erstellung des Abschlussberichts.
- Feedback zur Leistung des Prüfzentrums für die Durchführbarkeit/Auswahl künftiger Prüfzentren

Um die Stelle erfolgreich zu besetzen sollten Sie folgende Voraussetzungen mitbringen:

- Wissenschaftlicher Hintergrund mit minimum 2 Jahren Erfahrung als CRA
- Die Fähigkeit, 50% der Zeit zu reisen
- Kenntnisse der lokalen Vorschriften und der ICH/GCP-Richtlinien
- Fließende Englisch Kenntnisse in Wort und Schrift sowie Deutsch
- Vertrautheit mit dem risikobasierten Überwachungsansatz
- Erfahrung in der Durchführung von Site Selection, Initiation, Routine Monitoring und Close Out Visits sowohl aus der Ferne (falls in der Region zutreffend) als auch vor Ort
- Technologische Kenntnisse:
Ausgeprägte technische Fähigkeiten mit Erfahrung in Microsoft Office: Outlook, Excel, Word, CTMS, eCRF, eTMF, Digital IMP, eDiaries, Webportale von Anbietern, Skype for Business (RBM)

Was wird angeboten
- Arbeiten Sie für eine der beiden weltweit führenden CROs, sponsorenspezifisch in einem der weltweit führenden Pharmaunternehmen, voll integriert und aus der Perspektive des Sponsors
- Unbefristeter Vertrag,
- Homeoffice, wenn nicht auf Reisen
- Ausgezeichnete Karrieremöglichkeiten

Klingt, als würden Sie gut zu uns passen? Nehmen Sie noch heute Kontakt mit mir auf

**Benefits of Working in ICON**:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal oppo

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