CRA II/Sr CRA, Austria
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Job Description
Clinical Research Associate monitoring Austrian clinical trial sites for Syneos Health’s life sciences services. Ensuring GCP compliance, data integrity, site performance, and audit readiness.
Responsibilities:
- Perform site qualification, site initiation, interim monitoring, site management activities and close-out visits on-site or remotely
- Ensure regulatory, ICH-GCP/GPP and protocol compliance
- Evaluate site and site staff performance and recommend site-specific actions
- Escalate serious issues and develop action plans
- Verify informed consent processes and protect subject/patient confidentiality
- Assess subject/patient safety, protocol deviations/violations and pharmacovigilance issues
- Conduct source document review and verify clinical data in case report forms
- Resolve queries remotely and on site and guide site staff
- Verify compliance with electronic data capture requirements
- Perform investigational product inventory, reconciliation and storage/security reviews
- Review Investigator Site Files and reconcile them with Trial Master Files
- Document monitoring activities and maintain tracking systems
- Support subject/patient recruitment, retention and awareness strategies
- Manage site-level activities and communications to meet project objectives, deliverables and timelines
- Act as liaison with study site personnel and ensure site/project team training and compliance
- Attend investigator, sponsor, global monitoring and clinical training meetings
- Support audit readiness, audit preparation and follow-up actions
- Complete assigned training and maintain knowledge of applicable guidance, regulations and SOPs
Requirements:
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Previous monitoring experience in Austria required
- Previous monitoring experience in Germany and Switzerland preferred
- Good computer skills and ability to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Fluency in German and English
- Ability to manage required travel for monitoring visits in Austria, Germany and Switzerland
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations, when appropriate
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