Clinical Research Associate

IQVIA UK's Site Management (multi-sponsor) team is growing and seeking junior and experienced Clinical Research Associates. 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, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with sites to adapt, drive, and track subject recruitment plans 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, escalating quality issues as needed
• 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
• Ensure copies or originals of 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 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 needed

Requirements

• Experience of independent on-site monitoring
• 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 sites

Additional Information

• IQVIA is committed to integrity in our hiring process and maintains a zero-tolerance policy for candidate fraud.
• Please note - this role is not eligible for UK visa sponsorship