Senior Clinical Research Associate – Single Sponsor (Bucharest)

About the role

Syneos Health is seeking a Senior Clinical Research Associate to manage single‑sponsor studies from site qualification through close‑out. The role is based in Bucharest with a hybrid work model, supporting both on‑site and remote monitoring activities.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, and close‑out visits ensuring compliance with ICH‑GCP, regulatory requirements and protocol.
• Conduct source document review, verify data entry in CRFs, and resolve queries both on‑site and remotely.
• Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
• Maintain Investigator Site Files, reconcile with Trial Master Files, and ensure proper archiving of essential documents.
• Support subject recruitment, retention, and informed consent processes, and document all activities per SOPs.
• Provide mentorship to junior CRAs and may lead site‑level training sessions.

Required profile

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

Required skills

• Proficiency in electronic data capture (EDC) systems.
• Ability to conduct source document review and query resolution.
• Knowledge of investigational product handling and documentation.