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Clinical Research Associate (CRA2) - Multi-Sponsor Department

iqvia · Manchester

New
Mid 🇬🇧 English
Good Clinical Practice (GCP) Site monitoring

Job description

About the role

IQVIA UK's Site Management (multi-sponsor) team is growing and is looking for both junior and experienced Clinical Research Associates. The role covers site monitoring visits and the day-to-day management of assigned studies, working with sites to meet project needs.

Key responsibilities

  • Perform site monitoring visits (selection, initiation, monitoring and close-out) according to the contracted scope of work and regulatory requirements such as GCP and ICH guidelines.
  • Work with sites to adapt, drive and track the subject recruitment plan so it matches project needs.
  • Deliver protocol and study training to assigned sites and keep regular contact to manage ongoing expectations and issues.
  • Evaluate the quality and integrity of site practices, escalate quality issues as appropriate and manage study progress through regulatory submissions, recruitment, CRF completion and data queries.
  • Support the start-up phase where required, ensure site documents are available for the Trial Master File and that the Investigator's Site File is kept in line with GCP and local regulations.
  • Create and maintain documentation on site management and monitoring visits, including visit reports, follow-up letters and other study documents.
  • Liaise with study team members to support project execution.

Required profile

  • Experience of independent on-site monitoring and having managed multiple clinical trial protocols across diverse sites.
  • Life science degree or equivalent industry experience.
  • Flexibility to travel to sites.
  • The role is not eligible for UK visa sponsorship.

Required skills

  • In-depth knowledge of Good Clinical Practice (GCP) and ICH guidelines.

Questions fréquentes

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Source : ats:workday

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Published 7 hours ago

Expires 1 month from now

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iqvia

Manchester