Senior Clinical Research Associate II – Sponsor Dedicated (Cape Town)

About the role

Syneos Health is seeking a Senior Clinical Research Associate II (Sponsor‑dedicated) to join its Clinical Solutions team in Cape Town. The role will oversee the full lifecycle of investigator sites – from qualification and initiation through monitoring, management and close‑out – ensuring strict adherence to regulatory, ICH‑GCP and Good Pharmacoepidemiology Practices (GPP) standards.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, management and close‑out visits, either on‑site or remotely.
• Evaluate overall site performance, provide recommendations, and promptly escalate serious issues.
• Verify informed consent processes and maintain subject confidentiality.
• Assess protocol deviations, pharmacovigilance concerns and data integrity at each site.
• Conduct source document reviews and ensure compliance with the Clinical Monitoring/Site Management Plan.
• Maintain up‑to‑date knowledge of ICH/GCP guidelines, relevant regulations and company SOPs.

Required profile

• Significant experience as a Clinical Research Associate, preferably in a sponsor‑dedicated capacity.
• Strong understanding of regulatory requirements, ICH‑GCP and GPP.
• Excellent judgment to evaluate site performance and develop corrective action plans.
• Ability to protect patient confidentiality and handle sensitive data.
• Effective communication skills for reporting and escalation.

Required skills

• ICH‑GCP
• Good Pharmacoepidemiology Practices (GPP)
• Clinical monitoring
• Site management
• Source document review
• Pharmacovigilance

What we offer

• Career development and progression opportunities.
• Supportive line management and peer recognition.
• Technical and therapeutic area training.
• Inclusive culture with total rewards program.