Clinical Research Associate II - Client Dedicated (Austria)

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, in line with regulatory, ICH-GCP and Good Pharmacoepidemiology Practice (GPP) requirements.

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 release
• Review the Investigator Site File, reconcile it with the Trial Master File and document site activities
• Support recruitment and retention, prepare sites for audits and attend investigator and project meetings
• Manage site-level activities, budgets and timelines, and travel regularly (up to 75%)

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• Previous monitoring experience in Austria
• Fluency in German and English
• Ability to travel regularly, up to 75%

Required skills

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