Clinical Research Associate II (CRA II)

About the role

Syneos Health is seeking a Clinical Research Associate II (CRA II) to join its Clinical Solutions team. The CRA II will support drug development projects by performing site qualification, initiation, monitoring, management and close‑out activities, ensuring compliance with regulatory and protocol requirements.

Key responsibilities

• Conduct site qualification, initiation, interim monitoring, management and close‑out visits (on‑site or remotely) in line with ICH‑GCP and Good Pharmacoepidemiology Practice (GPP) standards.
• Evaluate site performance, provide recommendations, and promptly escalate serious issues to the project team.
• Maintain working knowledge of ICH/GCP guidelines, relevant regulations, and company SOPs.
• Verify that informed consent processes are correctly performed and documented for each subject.
• Protect subject confidentiality and assess safety or data‑integrity risks such as protocol deviations or pharmacovigilance issues.
• Perform source document reviews and verify required clinical data according to the Clinical Monitoring/Site Management Plan.

Required profile

• Demonstrated experience in clinical site monitoring and management.
• Strong understanding of ICH‑GCP guidelines and Good Pharmacoepidemiology Practice.
• Ability to assess site processes, identify deviations, and develop corrective action plans.
• Excellent communication skills for reporting and escalation.

Required skills

• ICH/GCP knowledge
• Good Pharmacoepidemiology Practice (GPP)
• Clinical site monitoring
• Source document review
• Informed consent verification

What we offer

• Career development and progression opportunities within a global life‑sciences services organization.
• Supportive line management, technical and therapeutic training, and peer recognition programs.
• An inclusive culture that values authenticity and diversity.
• Competitive total rewards package aligned with the company’s purpose – Driven to Deliver.