Clinical Research Associate II - Client Dedicated (Austria)
syneoshealth · AUT-Remote
Stellenbeschreibung
About the role
Syneos Health is hiring a CRA II for a client-dedicated position in Austria. The role covers site qualification, initiation, interim monitoring, site management and close-out visits, performed on-site or remotely, ensuring regulatory, ICH-GCP and protocol compliance.
Key responsibilities
- Evaluate site and site staff performance, escalate serious issues and develop action plans
- Verify informed consent, protect subject confidentiality and assess safety and data integrity risks
- Review source documents and CRFs, resolve queries and verify electronic data capture compliance
- Check investigational product inventory, dispensing and administration, and ensure proper labelling, import and return
- Review the Investigator Site File, reconcile it with the Trial Master File and document activities
- Support recruitment and retention, enter tracking data and liaise with sites or the Central Monitoring Associate
- Prepare for and attend investigator meetings, global project meetings and clinical training, and support audit readiness
Required profile
- Bachelor's degree or RN in a related field, or equivalent education, training and experience
- Previous monitoring experience in Austria
- Good computer skills and ability to adopt new technologies
- Fluency in German and English
- Able to travel regularly up to 75%
Required skills
- Knowledge of Good Clinical Practice (ICH-GCP) and other regulatory requirements
- Excellent communication, presentation and interpersonal skills
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Veröffentlicht vor 1 Tag
Läuft ab in 1 Monat
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syneoshealth
AUT-Remote
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