Clinical Research Associate II (CRA II)

About the role

Syneos Health is seeking a Clinical Research Associate II (CRA II) to support clinical trial sites across the drug development continuum. The CRA II will ensure regulatory compliance, data integrity, and patient safety while collaborating with investigators and internal project teams.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, management, and close‑out visits, either on‑site or remotely.
• Ensure adherence to ICH‑GCP, Good Pharmacoepidemiology Practice (GPP), and protocol requirements.
• Evaluate overall site performance, provide recommendations, and promptly communicate serious issues to the project team.
• Verify informed consent processes, protect patient confidentiality, and assess safety or data‑integrity concerns such as protocol deviations and pharmacovigilance issues.
• Conduct source document reviews of site records and medical charts in line with the Clinical Monitoring/Site Management Plan.

Required profile

• Demonstrated judgment and experience in clinical site monitoring.
• Working knowledge of ICH/GCP guidelines and relevant regulatory standards.
• Ability to assess site processes, identify risks, and develop corrective action plans.
• Strong attention to detail and commitment to patient confidentiality.

Required skills

• ICH/GCP compliance
• Good Pharmacoepidemiology Practice (GPP)
• Clinical monitoring and site management
• Source document review
• Pharmacovigilance awareness

What we offer

• Career development and progression opportunities.
• Supportive line management and technical training.
• Inclusive culture with total rewards program.