Senior Clinical Research Associate (Sr CRA I)

About the role

Syneos Health is seeking a Senior Clinical Research Associate (Sr CRA I) to join its Clinical Solutions team. In this role you will support drug development projects by ensuring sites are qualified, initiated, monitored, and closed‑out in compliance with regulatory and protocol requirements.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, management and close‑out visits, either on‑site or remotely.
• Ensure compliance with ICH‑GCP, Good Pharmacoepidemiology Practice (GPP) and study protocols.
• Evaluate site performance, provide recommendations, and promptly communicate serious issues to the project team.
• Verify that informed consent is obtained and documented correctly for each subject.
• Protect subject confidentiality and assess safety or data‑integrity concerns such as protocol deviations and pharmacovigilance issues.
• Conduct source document reviews and confirm accurate entry of required clinical data.

Required profile

• Proven experience in clinical site monitoring and management.
• Strong knowledge of ICH/GCP guidelines and applicable regulatory requirements.
• Familiarity with Good Pharmacoepidemiology Practice (GPP) and pharmacovigilance processes.
• Excellent communication skills and ability to work collaboratively with investigators and internal teams.

Required skills

• ICH/GCP guidelines
• Good Pharmacoepidemiology Practice (GPP)
• Clinical site monitoring
• Source document review
• Informed consent verification
• Pharmacovigilance assessment
• Regulatory compliance

What we offer

• Career development and progression opportunities.
• Supportive line management and technical training.
• Peer recognition and total rewards program.
• Inclusive culture that encourages authenticity.