Senior Clinical Research Associate responsible for site monitoring, site management, and oversight of clinical studies at investigator sites. Role involves ensuring protocol adherence, data integrity, regulatory compliance, and efficient resource management across assigned projects.
Responsibilities
Conduct routine site monitoring, pre-study visits, and clinical site closeout activities
Verify informed consent procedures and protocol adherence to regulatory requirements
Review source documents and CRFs to ensure data integrity and identify missing or implausible data
Manage small projects under direction of Project Manager; serve as lead monitor and prepare trip reports
Organize investigator meetings, participate in protocol development, and track SAE reporting and follow-up
Requirements




University or college degree in life science, nursing, medical, or laboratory technology certification
Minimum three years clinical monitoring experience in pharmaceutical or CRO settings
Thorough knowledge of regulatory requirements and drug development process
Fluency in local office language and English, written and verbal
Advanced site monitoring and site management skills with SAE reporting expertise
Valid driver's license and ability to travel *****% overnight
Strong planning, organization, and computer skills with minimal supervision needed

📌 Sr Cra I (Xico)
🏢 Fortrea
📍 Xico