Clinical Research Associate II – Peru

About the role

Syneos Health is seeking a Clinical Research Associate II (CRA II) to support clinical studies in Peru. The CRA II will conduct site qualification, initiation, monitoring, and close‑out activities, ensuring compliance with regulatory standards and study protocols.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, and close‑out visits, either on‑site or remotely.
• Ensure adherence to ICH‑GCP, Good Pharmacoepidemiology Practice (GPP), and local regulatory requirements.
• Evaluate overall site performance, provide recommendations, and promptly communicate serious issues to the project team.
• Verify informed consent processes and maintain subject confidentiality.
• Assess safety and data integrity risks, including protocol deviations and pharmacovigilance concerns.
• Conduct source document reviews and verify clinical documentation as outlined in the Clinical Monitoring/Site Management Plan.

Required profile

• Experience in clinical monitoring or site management within drug development studies.
• Working knowledge of ICH/GCP guidelines and relevant SOPs.
• Strong judgment to evaluate site performance and develop corrective actions.
• Ability to protect patient confidentiality and assess safety issues.

Required skills

What we offer

• Career development and progression opportunities.
• Supportive line management and technical training.
• Inclusive culture focused on delivering impact for patients.