CRA II - Dedicated Sponsor, Galicia (Remote)

About the role

Syneos Health is hiring a dedicated Clinical Research Associate II (CRA II) for its sponsor portfolio covering Galicia, working remotely from Madrid. The role covers site qualification, initiation, interim monitoring, site management and close-out, with the possibility of acting as primary liaison with study sites and supporting site recruitment and retention.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits (on-site or remotely), ensuring regulatory, ICH-GCP and protocol compliance
• Evaluate site and site staff performance, escalate serious issues and develop action plans
• Verify informed consent, protect subject confidentiality and assess factors affecting safety and data integrity
• Review source documents and CRFs, resolve queries and verify electronic data capture compliance
• Check investigational product inventory, dispensing and administration, and ensure proper labelling, import and release
• Review the Investigator Site File, reconcile it with the Trial Master File and support audit readiness
• Document activities, support subject recruitment and retention, and manage site-level communication within budget and timeline
• Prepare for and attend investigator meetings, project meetings and clinical training, and suggest potential sites based on local knowledge
• For Real World Late Phase studies: site support throughout the lifecycle, chart abstraction, data collection and knowledge of local study design requirements
• Collaborate with Sponsor affiliates, medical science liaisons and local country staff; may train junior staff

Required profile

• Bachelor's degree or RN in a related field, or equivalent combination of education, training and experience
• 3-4 years of experience as a CRA
• Knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements
• Experience in Immunology, Cardiology, Pulmonary Hypertension, Ophthalmology or Lipids
• Good computer skills and ability to embrace new technologies
• Excellent communication, presentation and interpersonal skills