Functional Service Provider CRA II – Melbourne/Sydney/Brisbane

About the role

Syneos Health is seeking a Functional Service Provider (FSP) Clinical Research Associate II to support clinical trials across Melbourne, Sydney and Brisbane. The role involves site qualification, initiation, monitoring, management and close‑out activities, ensuring compliance with regulatory and ICH‑GCP standards.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, management and close‑out visits, either on‑site or remotely.
• Ensure regulatory, ICH‑GCP and Good Pharmacoepidemiology Practice (GPP) compliance throughout the study.
• Evaluate overall site performance, provide recommendations, and promptly communicate serious issues to the project team.
• Maintain working knowledge of ICH/GCP guidelines, relevant regulations and company SOPs.
• Verify that informed consent is obtained and documented correctly for each subject.
• Protect subject confidentiality and assess factors affecting safety and data integrity, including protocol deviations and pharmacovigilance issues.
• Conduct source document review of site records and medical files as defined in the Clinical Monitoring/Site Management Plan.

Required profile

• Experience conducting site monitoring and management activities for clinical trials.
• Strong understanding of ICH/GCP guidelines, regulatory requirements and Good Pharmacoepidemiology Practice.
• Ability to assess site processes, identify issues and develop action plans.
• Excellent communication skills for escalating issues and collaborating with project teams.
• Commitment to maintaining subject confidentiality and data integrity.

Required skills

What we offer

• Career development and progression opportunities.
• Supportive line management and peer recognition programs.
• Technical and therapeutic area training.
• Total rewards program and inclusive culture.
• Opportunity to work with a global team of 25,000 colleagues.