Clinical Research Associate (CRAI/CRAII) – Sponsor Dedicated, Gauteng

About the role

Syneos Health is seeking a Sponsor‑dedicated Clinical Research Associate (CRAI/CRAII) to support clinical studies in Gauteng. The role involves overseeing site activities, ensuring compliance with regulatory and protocol requirements, and safeguarding patient safety and data integrity.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, management and close‑out visits, either on‑site or remotely.
• Assess site processes, conduct source document review and verify clinical data entered in case report forms.
• Ensure informed consent procedures are properly performed and documented.
• Identify and communicate protocol deviations, pharmacovigilance issues, and other compliance concerns to the project team.
• Maintain knowledge of ICH/GCP (or GPP) guidelines, applicable regulations and company SOPs.

Required profile

• Strong understanding of ICH/GCP (or Good Pharmacoepidemiology Practice) guidelines and relevant regulatory requirements.
• Ability to evaluate site performance and recommend corrective actions.
• Commitment to patient confidentiality and data integrity.
• Effective communication skills for escalating serious issues and developing action plans.

Required skills

• ICH/GCP compliance
• Clinical site monitoring
• Source document review
• CRF data verification
• Pharmacovigilance awareness

What we offer

• Career development and progression within a global biopharmaceutical solutions organization.
• Supportive line management and technical training.
• Inclusive Total Self culture promoting authenticity and belonging.