CRA II/Sr CRA, Austria

🔥 6 minutes ago

🇦🇹 Austria – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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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