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IQVIA in the United Kingdom is seeking a Clinical Research Associate to join our Site Management team. You will perform on-site monitoring visits across oncology trials, ensuring GCP compliance and high data quality.
Travel to trial sites will be required as needed, and you will collaborate with study teams to drive subject recruitment, manage documentation, and support start-up activities where appropriate.
Job Description IQVIA's Site Management (multi-sponsor) team are seeking a Clinical Research Associate to join us on our mission to help create a healthier world.
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. 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.
Experience of independent on-site monitoring of Oncology therapeutic area for unblinded studies. In depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Life science degree educated or equivalent industry experience Flexibility to travel to sites as required