Senior Clinical Research Associate – Single Sponsor – Bucharest

About the role

Syneos Health is seeking a Senior Clinical Research Associate (CRA) to manage single‑sponsor studies in Bucharest. The role involves overseeing site activities from qualification through close‑out, ensuring compliance with ICH‑GCP, regulatory requirements and study protocols.

Key responsibilities

• Conduct site qualification, initiation, interim monitoring, and close‑out visits both on‑site and remotely.
• Review source documents, verify CRF data accuracy, and resolve queries within agreed timelines.
• Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
• Maintain Investigator Site Files, reconcile with Trial Master Files, and ensure proper archiving.
• Support subject recruitment, retention, and informed‑consent processes.
• Provide mentorship to junior CRAs and may lead training sessions.

Required profile

• Bachelor’s degree or RN in a related field, or equivalent experience.
• Strong knowledge of Good Clinical Practice, ICH‑GCP, and applicable regulatory guidelines.
• Excellent communication, critical‑thinking, and interpersonal skills.
• Willingness to travel up to 75% of the time.

Required skills

• Proficiency with electronic data capture (EDC) systems.
• Experience in source document review and query resolution.
• Understanding of investigational product handling and inventory management.