Clinical Research Associate II – Remote (Romania)

About the role

Syneos Health is seeking a Clinical Research Associate II to support real‑world late‑phase studies in Romania. The role is home‑based and operates within a Functional Service Provider (FSP) single‑sponsor model, collaborating with site personnel and internal project teams.

Key responsibilities

• Perform site qualification, initiation, monitoring, management and close‑out visits remotely or on‑site, ensuring compliance with regulatory, ICH‑GCP and protocol requirements.
• Review informed consent processes, source documents, and case report forms for accuracy, completeness and query resolution.
• Manage investigational product inventory, reconciliation, storage, dispensing and compliance with labeling and security procedures.
• Maintain Investigator Site Files, reconcile with Trial Master Files and support audit readiness.
• Document activities through letters, trip reports and logs; track observations and action items in study tracking systems.
• Support subject recruitment, retention strategies and act as primary liaison with site staff.

Required profile

• Bachelor’s degree or RN in a related field, or equivalent experience.
• Strong knowledge of Good Clinical Practice, ICH guidelines and applicable regulatory requirements.
• Excellent communication, presentation and interpersonal skills.
• Ability to travel up to 75% of the time as required.

Required skills

• Good Clinical Practice (GCP) compliance
• ICH/GCP guideline application
• Electronic Data Capture (EDC) systems
• Source document review and query resolution
• Investigational product handling and inventory management