pIn 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.
/pullicompetitive compensation and benefits /liliCoordinate and complete assigned clinical trial activities per the study task matrix /liliReview country and investigator files and document findings in appropriate systems /liliSupport audit and inspection readiness by aligning study files with procedures /liliEnsure timely, high-quality delivery and escalate potential risks to project leads /liliProcess and maintain documentation within the electronic Trial Master File (eTMF) /liliReview eTMF and help resolve missing or outstanding documentation /liliAnalyze findings and assist with clarification of site documentation findings /liliSupport preparation and distribution of Investigator Site Files (ISFs), pharmacy binders,



and study supplies /liliAssist with study-specific translations and translation quality control /liliProvide administrative support for site activation and start-up activities /liliCoordinate with internal teams to keep site activation on critical path and timelines /liliSupport regulatory submissions and track local regulatory documentation /liliTransmit required documents to clients and IRBs/IECs as applicable /liliMaintain records of site communications and survey responses /liliReview survey information for completeness and relevance /liliSupport site follow-up plans and escalate concerns or risks /liliLiaise with internal teams to resolve investigator queries /liliSupport systems like Activate, eTMF, and other study platforms /liliMaintain accurate study databases and documentation, team lists, training requirements, activity plans, and vendor trackers /liliSupport Risk-Based Monitoring (RBM) activities where applicable /liliAssist with scheduling meetings and coordinating study communications /liliCollaborate with project team members to meet milestones and deadlines /liliCommunicate site-related issues and risks to clinical and project teams /liliHigh school diploma or equivalent /liliUniversity-level education in life sciences, healthcare, or related field is an advantage /liliRelevant experience is beneficial; capable of developing within clinical research /liliEquivalent combinations of education, training, and related experience may be considered /li /ulIn this role you will coordinate clinical trial activities and manage documentation to support audit readiness and regulatory compliance.
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📌 Clinical Trial Coordinator (Bologna)
🏢 Experteer Italy
📍 Bologna