Clinical Research Associate II (Madrid or Barcelona)

About the role

Syneos Health is hiring a CRA II (titled Site Management Associate II for Real World Late Phase studies) in Madrid or Barcelona, working on-site or remotely. The role covers site qualification, initiation, interim monitoring, site management and close-out, with up to 75% travel.

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
• Maintain the Investigator Site File and reconcile it with the Trial Master File
• Support recruitment and retention, enter tracking data and prepare sites for audits
• Attend investigator meetings, project meetings and clinical training, and suggest potential sites
• For Real World Late Phase: site support throughout the study lifecycle, chart abstraction, data collection and collaboration with sponsor affiliates and medical science liaisons

Required profile

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

Required skills

• Knowledge of Good Clinical Practice (ICH-GCP) and other applicable regulatory requirements
• Working knowledge of ICH/GCP guidelines, regulations and company SOPs