CRA II, Sponsor Dedicated – Immunology Studies

🕒 October 22

🇪🇸 Spain – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

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Syneos Health

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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 and escalate serious issues and develop action plans • Verify informed consent, subject confidentiality, safety and clinical data integrity • Assess site processes and conduct source document review • Verify clinical data accuracy and completeness in case report forms • Resolve queries remotely and on site within agreed timelines • Support clinical study data review, capture and electronic data capture compliance • Manage investigational product inventory, reconciliation, storage, dispensing and administration as applicable • Review and reconcile Investigator Site Files and Trial Master Files • Document monitoring activities through required project documents and tracking systems • Support subject recruitment, retention and awareness strategies • Manage site-level activities, communications, objectives, deliverables and timelines • Liaise with study site personnel and ensure site team training and compliance • Attend investigator, sponsor, global monitoring and clinical training meetings • Support audit readiness, audit preparation and follow-up actions • For real-world late-phase studies, provide site support throughout the study lifecycle, conduct chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior staff, identify out-of-scope activities, and suggest potential sites

🎯 Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience • Experience in immunology studies is required • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements • Good computer skills and ability to embrace new technologies • Excellent communication, presentation and interpersonal 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 • Remote work arrangement

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