Site Research Assistant
vor 4 Monaten
Sind Sie auf der Suche nach einer Chance oder einer neuen Herausforderung in der klinischen Forschung? Möchten Sie für ein branchenführendes Unternehmen arbeiten? IQVIA sucht derzeit nach einer Site Research Assistant (m/w/d), die/der am Standort in Hamburg die Durchführung einer klinischen Studie unterstützt.
Diese Teilzeitstelle (20 Stunden an 5 Tagen pro Woche) mit Start Anfang/Mitte Mai ist für ca. 18 Monate zu besetzen.
Zu den täglichen Aufgaben gehören:
- Koordinierung klinischer Forschungsstudien und Aufrechterhaltung eines sicheren Studienumfelds gemäß den Gesundheits
- und Sicherheitsrichtlinien unter der Leitung und Delegation des Principal Investigators
- Sicherstellung des Wohlergehens der Probanden, Vertretung der Freiwilligen und Eingehen auf deren Belange bei gleichzeitiger Gewährleistung der höchsten Qualität der Pflege
- Betreuung der Probanden und Unterstützung des Personals bei administrativen Aufgaben
- Pflege von Studienprotokollen, Fallberichtsformularen (CRFs), elektronischen Datenerfassungssystemen (EDC) und anderen Studiendokumenten auf dem neuesten Stand
- Planung und Koordinierung der logistischen Aktivitäten für Studienverfahren gemäß dem Studienprotokoll
- Durchführung der klinischen Vorbereitungen für die Studie, einschließlich der Beschriftung von Probenentnahmeröhrchen und -behältern, der Inventarisierung des erforderlichen Materials und der Einrichtung oder Behebung von Problemen mit der Ausrüstung und/oder der Studie
- Mithilfe bei der Dateneingabe, der Überprüfung der Datenqualität und der Beantwortung von Fragen, um die Einhaltung des Studienprotokolls und die Qualitätskontrolle auf inhaltliche Richtigkeit und Vollständigkeit sicherzustellen
- Unterstützung bei der Aufnahme von Probanden in die Studie durch Rekrutierung, Screening und Einweisung gemäß dem Studienprotokoll
- Sammeln, Erfassen und Berichten klinischer Daten und Befunde in angemessener Weise in CRFs und Zusammenarbeit mit dem Prüfarzt über studienbezogene unerwünschte Ereignisse und schwerwiegende unerwünschte Ereignisse gemäß dem Studienprotokoll
- Koordinierung mit dem Studienmonitor bei Studienproblemen und effektive Beantwortung der vom Monitor gestellten Fragen.
Wir suchen Kandidaten mit den folgenden Fähigkeiten und Erfahrungen:
- Mindestens ein Jahr einschlägige Erfahrung; oder eine gleichwertige Kombination aus Ausbildung, Schulung und Erfahrung
- Kenntnisse über klinische Studien, kombiniert mit fundierten Kenntnissen der abteilungs-, protokoll
- und studienspezifischen Arbeitsabläufe, Einverständniserklärungen und Studienpläne
- Grundkenntnisse der medizinischen Terminologie
- Ausgeprägte IT-Kenntnisse, geübt im Umgang mit MS Windows und Office-Anwendungen wie Access, Outlook, Excel und Word
- Ausgezeichnete zwischenmenschliche Fähigkeiten mit der Fähigkeit, effektive Arbeitsbeziehungen aufzubauen und zu pflegen
LI-CES
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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at
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