Functional Service Provider CRA II – Clinical Monitoring

About the role

Syneos Health is seeking a Functional Service Provider (FSP) Clinical Research Associate II to support clinical monitoring activities across sites in Melbourne, Sydney or Brisbane. You will work within a collaborative, patient‑centric environment to ensure trials are conducted in compliance with regulatory standards and study protocols.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, and close‑out visits, either on‑site or remotely.
• Assess site performance, identify deviations, and develop corrective action plans.
• Verify informed consent processes and protect patient confidentiality.
• Conduct source document review and ensure accurate data entry into case report forms (CRFs).
• Monitor pharmacovigilance issues and protocol compliance according to ICH‑GCP and Good Pharmacoepidemiology Practice (GPP) guidelines.

Required profile

• Experience in clinical site management and monitoring within pharmaceutical or CRO settings.
• Strong understanding of ICH‑GCP, GPP and relevant regulatory requirements.
• Ability to communicate findings clearly and escalate serious issues promptly.
• Attention to detail and commitment to data integrity and patient safety.

Required skills

• ICH/GCP compliance
• Good Pharmacoepidemiology Practice (GPP)
• Clinical monitoring and site management
• Source document review
• Case Report Form (CRF) data verification

What we offer

• Opportunities for career development and progression within a global biopharmaceutical organization.
• Supportive line management and peer recognition programs.
• Access to technical and therapeutic area training.
• A diverse, inclusive culture that values authenticity.