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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. The Clinical Research Associate will support Oncology studies and cover sites across the UK 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 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. Requirements 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 Please note - this role is not eligible for 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 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.

Clinical Research Associate Chesterfield, England, United Kingdom Full Time The Clinical Research Associate will support Oncology studies and cover sites across the UK 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 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. Requirements • 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

Managing the Quality Control and R&D department at the facility with overall responsibility for the facility’s raw material compliance, in-process and final product testing to ensure full compliance with the business needs, expectations and regulatory standards. • To accept work from the Group Compliance and perform tasks according to instructions provided in Quality Management System procedures and Masterfiles associated with the department., • Ensure all Quality Control records are maintained correctly and R&D reports are fully documented, completed and countersigned, as requested., • Perform QC tests in which satisfactory training has been completed and recorded in company training records, when the business requires cover for laboratory personnel., • Must comply with all Health & Safety, Quality Standards and Procedures established by the Company's Policies and act in accordance with the requirements of relevant legislation and any regulatory bodies at all times., • Must understand and comply with the Company’s Health & Safety Policies and Procedures and implement these, at all times, to ensure both the employee’s own safety and the safety of those who may be affected by the employee’s actions or omissions., • To develop both the laboratory and personnel to ensure that they are working within the guidelines of industry standards and guidelines and that tests are done in a timeframe to support production and release on materials. Quality Information System: • Must have a detailed awareness of the Quality Management System requirements relevant to the position as well as the potential effects of actions on the quality assurance process, with particular awareness of all quality aspects and requirements associated with output of data from the Quality Control and R&D functions and their compliance with standards as set out in the company Masterfiles., • Demonstrate a high-level understanding of Quality Management Systems and be aware that information regarding the quality assurance process can always be sought at any time by internal or external auditors. Therefore, a high level of concentration based on attention to detail, accuracy, precision and it is important they are experienced to ensure decision making is appropriate for the role., • All employees have a responsibility to highlight any possible quality improvement in their areas of activity. Requirements • At least five years’ experience from within a chemical / manufacturing environment with ISO 9001 certification., • At least five years’ laboratory experience in a chemical / manufacturing environment., • A level standard or equivalent to include at least one science related subject., • Comprehensive knowledge of BSI and Industry standards including an In-depth knowledge of ISO 9001

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