IQVIA UK are seeking experienced Clinical Research Associates (CRA II / SR CRA I / SR CRA II) to strengthen our cFSP (sponsor-dedicated) team. Responsibilities - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines - 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 - Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate - 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. May support start-up phase - 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 Requirements - Experience of independent on-site monitoring in the UK - Life science degree educated or equivalent industry experience - Flexibility to travel to sites as required LI-ADAMTHOMPSON Please note - this role is not eligible for UK visa sponsorship IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes. To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled