Reading, GBR
10 hours ago
Senior Clinical Research Associate, Scotland
**IQVIA CFSP (sponsor-dedicated) are seeking Senior Clinical Research Associates (SR CRA I / SR CRA II) in Scotland to join us on our mission to help create a healthier world.** **Apply today and forge a career with greater purpose, make an impact and never stop learning!** **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.** **If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.** **Requirements** **Experience of independent on-site monitoring.** **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.** **\#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 leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled
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