CRA II / Senior CRA - Client Dedicated (Austria)

About the role

Syneos Health is looking for an experienced CRA to join its team in Austria for a single-sponsor partnership. The role covers site qualification, initiation, interim monitoring, site management and close-out visits, performed on-site or remotely, and requires travel to Austria, Germany and Switzerland.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and/or GPP and protocol compliance
• Evaluate site and site staff performance, escalate serious issues and develop action plans
• Verify informed consent, protect subject confidentiality and assess factors affecting safety and data integrity
• 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 release/return
• Review the Investigator Site File, reconcile it with the Trial Master File and document activities
• Support recruitment and retention, enter tracking data and prepare sites for audits
• Act as liaison with sites, attend investigator and sponsor meetings and complete required training

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• Previous monitoring experience in Austria required; experience in Germany and Switzerland preferred
• Fluency in German and English
• Ability to manage travel for monitoring visits in Austria, Germany and Switzerland

Required skills

• Knowledge of Good Clinical Practice (ICH-GCP) and other applicable regulatory requirements
• Good computer skills and willingness to adopt new technologies
• Excellent communication, presentation and interpersonal skills