Clinical Research Associate II, Oncology

About the role

IQVIA UK's Site Management (multi-sponsor) team is growing and is looking for experienced Clinical Research Associates. This is a CRA II Oncology position based in Manchester, working with sites to monitor clinical trials in line with their contracted scope of work and regulatory requirements.

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 and improves predictability.
• 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 track regulatory submissions, approvals, recruitment, CRF completion and data queries.
• Support the start-up phase where needed, 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, monitoring findings and action plans through 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.