In this role you will coordinate clinical trial activities and manage documentation to support audit readiness and regulatory compliance. You will work within cross-functional teams to ensure timely, high-quality deliverables and maintain study systems like eTMF. You will contribute to site activation, regulatory submissions, and study coordination, applying a proactive, detail-oriented approach. This is an opportunity to shape trial operations in a global, collaborative environment and drive impactful results in clinical research.
- competitive compensation and benefits
- Coordinate and complete assigned clinical trial activities per the study task matrix
- Review country and investigator files and document findings in appropriate systems
- Support audit and inspection readiness by aligning study files with procedures
- Ensure timely, high-quality delivery and escalate potential risks to project leads
- Process and maintain documentation within the electronic Trial Master File (eTMF)
- Review eTMF and help resolve missing or outstanding documentation




- Analyze findings and assist with clarification of site documentation findings
- Support preparation and distribution of Investigator Site Files (ISFs), pharmacy binders, and study supplies
- Assist with study-specific translations and translation quality control
- Provide administrative support for site activation and start-up activities
- Coordinate with internal teams to keep site activation on critical path and timelines
- Support regulatory submissions and track local regulatory documentation
- Transmit required documents to clients and IRBs/IECs as applicable
- Maintain records of site communications and survey responses
- Review survey information for completeness and relevance
- Support site follow-up plans and escalate concerns or risks
- Liaise with internal teams to resolve investigator queries
- Support systems like Activate, eTMF, and other study platforms
- Maintain accurate study databases and documenta

📌 Clinical Trial Coordinator (Bologna)
🏢 Experteer Italy
📍 Bologna