Experienced CRA - Single Sponsor Dedicated

About the role

iQVIA cFSP (sponsor-dedicated) is looking for experienced Clinical Research Associates in the UK, based in Reading. The role covers site monitoring for a dedicated sponsor, working on medicines at the forefront of new drug development. The role is not eligible for UK visa sponsorship.

Key responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) according to the contracted scope of work and regulatory requirements, including 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 project expectations and issues.
• Evaluate the quality and integrity of site practices, escalate quality issues and track regulatory submissions, enrolment, 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 and follow-up letters.
• Liaise with study team members to support project execution.

Required profile

• At least 6 months of experience in independent on-site monitoring.
• Proven track record managing multiple clinical trial protocols across diverse investigative sites.
• Life science degree or equivalent industry experience.
• Willingness to travel to sites.

Required skills

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