Job OverviewPerform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.Essential Functions:• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF)



is maintained in accordance with GCP and local regulatory requirements.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.• Collaborate and liaise with study team members for project execution support as appropriate.• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.Qualifications:• Bachelor's and Master's Degree in scientific discipline or health care• Requires at least 3 years of year of on-site monitoring experience• In possession of CRA Certification according to Ministerial Decree dated 15.11.2011• Good

📌 Experienced CRA, Sponsor Dedicated (Italia)
🏢 Iqvia
📍 Italia