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Clinical Project Assistant/ Specialist
vor 3 Monaten
Sie haben Erfahrung als Clinical Project Assistant/ Specialist (CTA) und sind auf der Suche nach einem neuen spannenden Projekt? Dann dürfte folgende Stelle sehr interessant für Sie sein:
**Clinical Project Assistant (Freelance)**
Ihre künftigen Aufgaben:
- Enge Zusammenarbeit bzw. Unterstützung des Clinical Operations Teams hinsichtlich der Planung und Durchführung der klinsichen Studien
- Koordination und Teilnahme an Clinical Trial Team-Sitzungen, Vorbereitung von Sitzungsprotokollen und Verfolgung / Nachverfolgung ausstehender Maßnahmen
- Verwalten der Trail Master Files (TMF) und Sicherstellen der Implementierung QC-Plans
- Koordination der Einholung von Studiendokumenten in Zusammenarbeit mit den Prüfärzten/Studienteams
- Sicherstellung der Korrektheit und Qualität von Studiendokumenten zur Einreichung Klinischer Studien
- Organisation, Archivierung und Aktualisierung von Studiendokumenten für die jeweiligen Studienteams gemäß internen Vorgaben
- Eingabe und Nachverfolgung von Studieninformationen in Datenbanken sowie Pflege von Statuslisten
- Unterstützung des Vertragswesens und Fertigstellung von Studienverträgen mit den Prüfzentren im engen Austausch mit beratenden Rechtsabteilungen
- Koordination, Vorbereitung und Verwaltung von Studienmaterialien oder Gerätschaften (u.a. Studienordnern für die Prüfärzte)
Das zeichnet Sie aus:
- mindestens ein bis zwei Jahre Erfahrung in der klinischen Forschung
- Naturwissenschaftliches Studium, Ausbildung zum medizinischen Dokumentar oder vergleichbare medizinische Ausbildung
- Gute Selbstorganisation, kooperativ, flexibel, Einsatzwille, auch unter Zeitdruck belastbar
- Selbstständige Bearbeitung aller organisatorischen und administrativer Aufgaben
- Gute Englisch
- und EDV-Kenntnisse
Parameter:
- Start: März
- Dauer: 12 Monate ++
- Homebased
- Volumen: 2-4 Tage/ Woche
Haben Sie Interesse an diesem Projekt?
Dann freue ich mich auf Ihre Bewerbung und ein interessantes Gespräch mit Ihnen Rückfragen gerne unter: +49 (0) 895519744
Viele Grüße aus München,
Stefan Blöchl
Stichworte:
Pharmazie, Pharma, Medizin, Freelance, freiberuflich, befristet, Medical, Biologie, Onkologie, Orphan, drug, Master, Bachelor, GCP, GxP, Clinical, CRO, Studien, klinisch, TMF, Prüfplan, Prüfbogen, Monitor, CRA, CTA, Clinical Research Associate. Trial Master File; GCP, GxP, Clinical; CTS, Biotech, Biotechnologie
