CRA II

🕒 October 6

🇦🇹 Austria – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

🗣️🇩🇪 German Required

Where this job comes from

Posted on Syneos Health's careers page, not through a job board

First seen by Remote Rocketship October 6

Logo of Syneos Health

Syneos Health

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 and/or GPP and protocol compliance • Evaluate site and site staff performance and provide recommendations and action plans • Verify informed consent processes, subject/patient confidentiality, safety and clinical data integrity • Assess site processes and conduct source document review • Verify clinical data entered in case report forms is accurate and complete • Resolve queries remotely and on site and guide site staff • Manage investigational product inventory, reconciliation, storage, dispensing and administration checks • 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, communications, budgets and timelines • Liaise with study site personnel and ensure site team training and compliance • Prepare for and attend investigator and sponsor meetings and clinical training sessions • Support audit readiness and preparation for audits and follow-up actions • Maintain knowledge of applicable guidelines, regulations and company SOPs and complete required training

🎯 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 • 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 of up to 75% on a regular basis

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture

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