Clinical Research Associate

• Serve as the main CTI contact for assigned study sites
• Conduct pre-study, site initiation, interim monitoring, and close-out visits
• Complete site visit deliverables with quality and within Monitoring Plan timelines
• Assist with or oversee study start-up, feasibility, pre-study activities, and site selection
• Collect, review, and track essential and regulatory documents
• Participate in required general and study-specific training
• Participate in investigator, client, and project team meetings, including presentations when needed
• Create and implement subject enrollment strategies
• Ensure proper storage, dispensation, and accountability of investigational product and trial-related materials
• Provide ongoing site-status updates to the Clinical Project Manager
• Conduct remote monitoring in accordance with the study-specific Monitoring Plan
• Track subject status, CRF retrieval, source document review, regulatory documents, and investigational product using systems and reports
• Assist with project-specific activities as a member of the Project Team

• 3–5 years of clinical research experience as a CRA or related profession
• Independent monitoring experience in Germany
• Life science background
• Excellent knowledge of ICH-GCP and regulatory requirements
• Fluent spoken and written English at least Level B2
• Ability to conduct pre-study, site initiation, interim monitoring, and close-out visits
• Ability to perform site management and remote monitoring activities
• Ability to manage investigational product and trial-related materials
• Ability to collect, review, and track essential and regulatory documents

• Structured mentoring program
• Leadership development courses
• Dedicated training department
• Ongoing education support
• Hybrid work opportunities
• CTI Cares community and charitable involvement opportunities
• Work contributing to life-changing treatments for patients with chronic and critical illnesses