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...

📌 Clinical Trial Coordinator (Bologna)
🏢 Altro
📍 Bologna