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German Clinical Research Associate

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SIRE Life Sciences® ist der Marktführer in der Recruitment-Branche der Life-Science-Industrie. Wir glauben, dass die Recruitment-Branche noch einige Verbesserungen in Technologie und inhaltlicher Innovation vornehmen kann. Wir lieben Technologie und in einem Markt, der auf Life-Science orientiert ist und sich auf den wissenschaftlichen Aspekt konzentriert, können wir nicht zurückbleiben; wir betreiben Recruitment-Wissenschaft. Wir investieren einen großen Teil unseres Umsatzes in Technologie, wodurch wir einzigartige Ressourcentechnologie verwenden können. Durch die Verwendung von hochgradig entwickelten Algorithmen, ist es unserem Team an Ressourcen- & Datenstrategen© möglich, das am meisten ausgebaute, detaillierteste und vollständige Life-Science-Netzwerk in Europa zu erhalten. Durch diese großen Datenmengen (Big Data) ist es uns möglich, Reverse Recruitment© zu betrieben: wir analysieren erst tief gehend den Markt, bevor wir uns in den Markt begeben. Da wir den gesamten Markt analysieren, können wir Fakten und Daten vergleichen. Dadurch können wir Facts & Big Data Recruitment© betrieben, und sicherstellen, dass wir oder besser gesagt, Sie, die besten Karriere finden.

The company

This international company has a small and cosy office with lab in the sparkly suburbs of Gent. They're focussing on viruses mainly.

Role description

The role of CRA involves coordination of all the aspects of the monitoring and site management. This according to ICH-GCP guidelines, FDA guidelines and local regulations. You'll conduct visits to the sites and do the documentation and protocol. also you're responsible for the data. Next to this you'll be responsible for assisting the project manager and clinical team manager on the projects they're working on. you wil take the lead when this is required.

Responsibilities

- All aspects of site management as prescribed in the project plans
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
- Negotiation of study budgets with potential investigators and collaboration with the legal department with statements of agreements
- Reporting, production of reports, narratives and follow up of SAEs.
- Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on client data management systems

Requirements

- University degree in a science related field or a certified health care professional or equivalent certification/licensure from an appropriately accredited institution
- Considerable clinical research monitoring experience (comparable to 5 years) with a demonstrated high level of expertise in all aspects of clinical monitoring
- Fluency in English and in the country's native language (dutch) and German
- Valid Driver's License where applicable
- In some cases an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered



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SIRE Life Sciences

Listed by: SIRE Life Sciences
Listed on: 20-07-2017
Country: Belgium
Employment: Freelance
Expertise: 3 - 5 years
Location Type: On location
Language: English
Sector: Pharmaceutical
Specialisation: Pharmacovigilance

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Contact

THE NETHERLANDS

Spiegelhof
Herengracht 466
1017CA Amsterdam
+31 (0) 20 658 9800

BELGIUM

Science 14 Atrium
14b, Rue de la Science
1040 Bruxelles
+32 (0) 2 588 1277

GERMANY

Fünf Höfe
Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

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