Senior Clinical Research Associate – Sponsor Dedicated FSP

About the role

Syneos Health is seeking a Senior Clinical Research Associate (CRA) to support sponsor‑dedicated Functional Service Provider (FSP) projects. The CRA will manage site activities from qualification through close‑out, ensuring compliance with regulatory and protocol requirements.

Key responsibilities

• Conduct site qualification, initiation, monitoring, and close‑out visits on‑site or remotely.
• Review source documents, verify data entry in CRFs, and resolve queries within timelines.
• Manage investigational product inventory, reconciliation, and compliance with labeling and storage requirements.
• Maintain Investigator Site Files, reconcile with Trial Master Files, and document activities per SOPs.
• Support subject recruitment, retention, and informed‑consent processes.
• Collaborate with project teams, act as liaison to sites, and contribute to audit readiness.

Required profile

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

Required skills

• Good Clinical Practice (GCP) and ICH guidelines.
• Good Pharmacoepidemiology Practice (GPP).
• Source document review and data verification.
• Electronic data capture (EDC) systems.
• Investigational product handling and inventory management.