Clinical Research Associate II, Slovenia (Sponsor-Dedicated)

About the role

Syneos Health is hiring a CRA II for a sponsor-dedicated position in Slovenia, working remotely. The role covers site qualification, initiation, interim monitoring, site management and close-out, ensuring regulatory, ICH-GCP and protocol compliance. For Real World Late Phase studies, the title used is Site Management Associate II, with added responsibilities such as chart abstraction and site support throughout the study lifecycle.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, on-site or remotely, and escalate serious issues to the project team
• 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 return
• Review the Investigator Site File, reconcile it with the Trial Master File and ensure document archiving
• Document activities, support recruitment and retention, enter data into tracking systems and manage site-level communication
• Act as liaison with sites, prepare for investigator meetings and audits, and train site staff
• For Real World Late Phase: support sites from identification to close-out, abstract charts, collect data and suggest potential sites

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• Knowledge of Good Clinical Practice and ICH guidelines and other regulatory requirements
• Good computer skills and willingness to adopt new technologies
• Excellent communication, presentation and interpersonal skills
• Able to travel regularly up to 75%