This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Act as the primary CTI liaison for designated study sites

• Perform pre-study assessments, site initiation, interim monitoring, and close-out visits

• Fulfill site visit obligations within the timelines outlined in the monitoring plan, adhering to relevant regulatory, SOP, and ICH-GCP standards

• Aid in or supervise study initiation, feasibility assessments, pre-study tasks, and site selection

• Gather, evaluate, and monitor essential and regulatory documentation

• Complete necessary general and study-specific training programs

• Engage in meetings with investigators, clients, and project teams, including delivering presentations

• Develop and execute strategies for subject enrollment

• Ensure the proper storage, distribution, and accountability of investigational products and trial-related materials

• Conduct site management tasks and provide updates on site status to the Clinical Project Manager

• Carry out remote monitoring in accordance with the study-specific Monitoring Plan

• Utilize systems and reports to monitor subject status, CRF retrieval/source document reviews, regulatory documents, and investigational products

• Contribute to project-specific endeavors as a member of the Project Team

⛳️ Requirements

• 3–5 years of experience in clinical research as a CRA or a related role in Germany

• Experience in independent monitoring within Germany

• Background in life sciences

• Comprehensive knowledge of ICH-GCP and regulatory standards

• Proficient (minimum Level B2) in both spoken and written German and English

🏝️ Benefits

• Structured mentoring program

• Leadership development courses

• Dedicated training department

• Ongoing education support

• Hybrid work opportunities

• CTI Cares community and global giving opportunities

• Support for work-life balance