CRA2 - Multi-Sponsor Department

IQVIA UK's Site Management (multi-sponsor) team is growing and seeking junior and experienced Clinical Research today and forge a career with greater purpose, make an impact, and never stop learning!ResponsibilitiesPerform 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) guidelinesWork with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictabilityAdminister protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issuesEvaluate 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 appropriateManage 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 phaseEnsure 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 requirementsCreate 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 documentationCollaborate and liaise with study team members for project execution support as appropriateRequirementsExperience of independent on-site monitoringYou 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) guidelinesLife science
degree educated or equivalent industry experienceFlexibility to travel to sitesPlease note - this role is not eligible for UK visa sponsorshipIQVIA 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 IQVIA 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.SummaryLocation: Manchester, England, United Kingdom; Leeds, West Yorkshire, United Kingdom; Reading, Berkshire, United Kingdom; London, United KingdomType: Full time