CRA II - Dedicated Sponsor, Gastroenterology & Genitourinary

About the role

Syneos Health is hiring a Clinical Research Associate II (CRA II) in Madrid as a dedicated sponsor representative for gastroenterology and genitourinary studies. The role covers site qualification, initiation, interim monitoring, site management and close-out, performed on-site or remotely, and includes site support throughout the study lifecycle.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, 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 and reconcile it with the Trial Master File
• Support subject recruitment and retention, enter tracking data and prepare sites for audits
• Attend investigator meetings, project meetings and clinical training, and suggest potential sites based on local knowledge
• For Real World Late Phase studies: chart abstraction, data collection and knowledge of local study design requirements

Required profile

• Bachelor's degree or RN in a related field, or equivalent combination of education, training and experience
• 2-5 years of experience as a CRA
• Good computer skills and willingness to adopt new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to manage travel of up to 75% regularly

Required skills

• Knowledge of Good Clinical Practice (ICH-GCP) and other applicable regulatory requirements
• ICH-GCP guidelines and relevant regulations