15 ago - Bologna
Experteer Italy
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… #J-18808-Ljbffr
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