Clinical Trial Coordinator
Pubblicato il 19-08-2026 - Altro in Bologna
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 documentation, team lists, training requirements, activity plans, and vendor trackers
Support Risk-Based Monitoring (RBM) activities where applicable
Assist with scheduling meetings and coordinating study communications
Collaborate with project team members to meet milestones and deadlines
Communicate site-related issues and risks to clinical and project teams
High school diploma or equivalent
University-level education in life sciences, healthcare, or related field is an advantage
Relevant experience is beneficial; capable of developing within clinical research
Equivalent combinations of education, training, and related experience may be considered
In this role you will coordinate clinical trial activities and manage documentation to support audit readiness and regulatory compliance. Yo…
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