Clinical Research Associate II

Responsibilities

• Conduct site visits including pre-study, site initiation, interim monitoring, and close-out visits
• Manage study site activities in adherence to regulatory guidelines, SOPs, and ICH GCP
• Collect, review, and track essential regulatory documents and manage ISF/TMF for assigned sites
• Implement subject enrollment strategies and ensure proper storage and accountability of Investigational Product (IP)
• Perform remote monitoring and utilize systems to track subject status and source document review (SDV)
• Identify site issues and implement corrective actions or escalate as appropriate
• Liaise with Clinical Data Management for data cleaning activities and provide updates to the Clinical Project Manager

Requirements

• At least 2 years of clinical trial monitoring experience
• Bachelor's Degree or higher in an allied health field (nursing, pharmacy, or natural science) or equivalent professional experience
• Previous experience conducting clinical research studies in a hospital, pharmaceutical, or CRO setting
• Strong understanding of drug development processes and ICH/GCP regulations

About the Company

CTI is a global clinical research organization dedicated to supporting the drug development process through expert monitoring and clinical trial management services.