Clinical Research Associate (Junior / CRA / Senior CRA) (m/w/d)
IHF GmbH
Gestalten Sie mit uns die Zukunft der Herz-Kreislauf-Forschung Die IHF GmbH – Institute for Myocardial Infarction Research – zählt zu den führenden Forschungsinstituten im Bereich der kardiovaskulären Medizin. Seit über 25 Jahren konzipieren, koordinieren und begleiten wir nationale und internationale klinische Studien, Register und Versorgungsforschungsprojekte mit dem Ziel, die Behandlung von Patientinnen und Patienten nachhaltig zu verbessern. Zur Verstärkung unseres Clinical Operations Teams suchen wir zum nächstmöglichen Zeitpunkt einen engagierten Clinical Research Associate (m/w/d) . Je nach Qualifikation und Berufserfahrung ist ein Einstieg als Junior CRA, CRA oder Senior CRA möglich. Ihre Aufgaben: Eigenständiges Monitoring klinischer und nicht-interventioneller Studien an Prüfzentren in Deutschland sowie der DACH-Region Vorbereitung, Durchführung und Nachbereitung von Initiierungs-, Monitoring- und Close-out-Visits Sicherstellung der Einhaltung von Studienprotokollen, ICH-GCP-Richtlinien sowie nationaler und internationaler regulatorischer Anforderungen Überprüfung der Datenqualität, Studiendokumentation und Quellunterlagen Unterstützung, Schulung und Motivation der Teams an den Studienzentren Erstellung von Monitoringberichten sowie weiterer studienrelevanter Dokumentation Teilnahme an Investigator Meetings, Projektbesprechungen und Schulungsveranstaltungen Enge Zusammenarbeit mit Projektmanagement, Site Management, Data Management und weiteren interdisziplinären Teams Unterstützung bei der kontinuierlichen Optimierung interner Prozesse und Qualitätsstandards Erfolgreich abgeschlossenes Studium der Naturwissenschaften, Gesundheitswissenschaften, Medizin, Pharmazie oder eine vergleichbare Qualifikation Idealerweise eine Zusatzausbildung zum Clinical Research Associate (CRA) Berufserfahrung im Monitoring klinischer oder nicht-interventioneller Studien; auch motivierte Berufseinsteiger mit entsprechender Qualifikation sind willkommen Fundierte Kenntnisse der ICH-GCP-Richtlinien sowie relevanter regulatorischer Anforderungen Idealerweise Erfahrung im Bereich Kardiologie oder Herz-Kreislauf-Forschung Strukturierte, selbstständige und qualitätsorientierte Arbeitsweise Ausgeprägte Kommunikations- und Organisationsfähigkeit Hohe Eigeninitiative, Engagement und Teamfähigkeit Reisebereitschaft für Monitoringbesuche innerhalb der DACH-Region (ca. 30–50 %) Sehr gute Deutschkenntnisse (mindestens C1-Niveau) sowie sehr gute Englischkenntnisse in Wort und Schrift Sicherer Umgang mit MS Office-Anwendungen sowie idealerweise Erfahrung mit EDC-Systemen und studienspezifischen Softwarelösungen Wir bieten Ihnen: Eine verantwortungsvolle Position in einem renommierten Forschungsinstitut mit hoher wissenschaftlicher Reputation Mitarbeit an innovativen nationalen und internationalen Forschungsprojekten mit direktem Einfluss auf die Patientenversorgung Ein kollegiales, engagiertes und professionelles Team mit kurzen Entscheidungswegen Umfassende Einarbeitung sowie individuelle Weiterbildungs- und Entwicklungsmöglichkeiten Flexible Arbeitszeiten und ein hybrides Arbeitsmodell mit Homeoffice-Möglichkeiten Moderne Arbeitsausstattung und digitale Arbeitsprozesse Attraktive Vergütung, vermögenswirksame Leistungen sowie weitere Benefits Langfristige Perspektive in einem stabil wachsenden Unternehmen Haben wir Ihr Interesse geweckt? Dann freuen wir uns auf Ihre vollständigen Bewerbungsunterlagen unter Angabe Ihrer Gehaltsvorstellung sowie Ihres frühestmöglichen Eintrittstermins! #J-18808-Ljbffr IHF GmbH
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