Senior CRA

🕒 October 16

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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 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 • Communicate or escalate serious issues and develop action plans • Verify informed consent, subject/patient confidentiality, safety and clinical data integrity • Assess site processes and conduct source document review • Verify clinical data accuracy and completeness and drive query resolution • Support clinical study data review and capture and verify electronic data capture compliance • Perform investigational product inventory, reconciliation and storage/security reviews • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities and track observations, status and action items • Support subject/patient recruitment, retention and awareness strategies • Manage site-level activities and communications to meet project objectives, deliverables and timelines • Liaise with project site personnel and ensure assigned sites and site team members are trained and compliant • Prepare for and attend investigator and sponsor meetings and clinical training sessions • Support audit readiness and audit preparation and follow-up actions • Provide training or mentorship to junior CRAs and perform training/sign-off visits as assigned • Perform clinical operations lead tasks under supervision when assigned

🎯 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 Germany • Good computer skills and ability to embrace new technologies • Fluency in German and English • Excellent communication, presentation and interpersonal skills • Basic level of critical thinking skills • 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 • Reasonable accommodations, when appropriate

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