Experteer Overview As a CRA for PPD, you monitor investigator sites using a risk-based approach to ensure protocol adherence and data integrity. You will work with cross-functional teams to identify and resolve issues, contributing to high-quality clinical trial delivery on a global scale. Your role supports data accuracy, regulatory compliance, and site performance across study phases, including cell & gene therapy programs. You'll collaborate with clients and investigators to ensure timely, compliant trial conduct and documentation. This opportunity offers a chance to impact patient outcomes while working in a collaborative, flexible environment.
Retribuzione / Benefits Monitor investigator sites using risk-based monitoring and root-cause analysis to ensure compliance and mitigate risks
Ensure data accuracy via SDR, SDV, and CRF review during on-site and remote monitoring
Assess investigational product through inventory checks and records review
Document observations and elevate deficiencies with timely resolution
Maintain communication with sites and project team to verify protocol adherence and data recording
Participate in investigator payments, issue resolution, and investigator meetings as needed
Initiate sites per procedures to ensure regulatory and ICH GCP compliance; conduct trial close-out and materials retrieval
Ensure essential documents are complete per ICH-GCP and regulatory standards; perform on-site file reviews
Provide trial status updates to the Clinical Team Manager and update study systems per conventions
Support project work and process improvement through collaboration and knowledge sharing
Contribute to project publications/tools and other project initiatives
Responsabilità University degree in a science-related field
Understanding of ICH-GCP, EU and FDA requirements
Fluency in English
Valid driver's license
Proven clinical monitoring skills
Experience with Cell & Gene Therapy studies
Strong medical terminology knowledge and regulatory litera
📌 Senior Clinical Research Associate (Italia)
🏢 Altro
📍 Italia
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