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Experienced CRA - Single Sponsor Dedicated
Posted 7 days 11 hours ago by IQVIA LLC
Permanent
Full Time
Other
England, United Kingdom
Job Description
Experienced CRA - Single Sponsor Dedicated page is loaded Experienced CRA - Single Sponsor Dedicatedlocations: Reading, Berkshire, United Kingdomtime type: Full timeposted on: Posted Todayjob requisition id: RJoin Us on Our Mission to Drive Healthcare ForwardIQVIA cFSP (sponsor-dedicated) are seeking experienced Clinical Research Associates in the UK. IQVIA is recognized as in its category on the 2025 Fortune(R) World's Most Admired Companies(TM) list for the FOURTH consecutive year! We offer genuine career development opportunities for those who want to grow as part of the organization. The chance to work on cutting edge medicines at the forefront of new medicines development. IQVIA has access to significant data pools allowing better site selection and recruitment. This helps drive performance of sites making the CRA role more efficient and discussions at site more productive. Next generation clinical development!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 appropriateRequirements Experience of independent on-site monitoring (minimum 6 months). You have successfully managed multiple clinical trial protocols across diverse investigative sites. 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 sitesApply today and forge a career with greater purpose, make an impact, and never stop learning! 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 atIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.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.
IQVIA LLC
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