Clinical Research Associate II - Italy (Home Based)

About the role

Syneos Health is hiring a CRA II for Italy, working from home. The role covers site qualification, initiation, interim monitoring, site management and close-out visits, performed on-site or remotely, in line with regulatory, ICH-GCP and Good Pharmacoepidemiology Practice (GPP) requirements. For Real World Late Phase studies, the title used is Site Management Associate II.

Key responsibilities

• Evaluate site and site staff performance, escalate serious issues and develop action plans
• Verify informed consent, protect subject confidentiality and assess safety and data integrity risks
• 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
• Document activities, support recruitment and retention, and enter data into tracking systems
• Prepare for and attend investigator meetings, global project meetings and clinical training, and support audit readiness
• For Real World Late Phase: site support throughout the study lifecycle, chart abstraction, data collection and collaboration with sponsor affiliates, medical science liaisons and local country staff

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 travel of up to 75% regularly

Required skills

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

The potential annual gross salary starts at EUR 42,000.