CRA2 - Multi-Sponsor Department

IQVIA LLC; Leeds; On-site; GBP 32,000 - 52,000; Full time

Job summary

IQVIA UK Site Management team seeks junior and experienced Clinical Research professionals to perform on-site monitoring visits across multiple sponsors. You will drive subject recruitment plans, train site staff on the protocol, and ensure regulatory compliance throughout the study lifecycle.

The role requires independent monitoring experience, strong GCP/ICH knowledge, and willingness to travel between sites. UK visa sponsorship is not available for this position.

Qualifications

• Experience of independent on-site monitoring.
• Managed multiple clinical trial protocols across diverse investigative sites.
• In depth knowledge of GCP and ICH guidelines.
• Life science degree or equivalent industry experience.
• Flexibility to travel to sites.
• Role not eligible for UK visa sponsorship.

Responsibilities

• Perform site monitoring visits per contracted scope of work and regulatory requirements (GCP/ICH).
• Work with sites to adapt, drive, and track subject recruitment to improve predictability.
• Administer protocol and study training to assigned sites and maintain regular communication.
• Evaluate site practices for protocol conduct and regulatory adherence; escalate issues.
• Track regulatory submissions, enrolment, CRF completion, data query resolution.
• May support start-up phase.
• Ensure site documents are available for filing in TMF and ISF maintained per GCP/local regs.
• Create and maintain site management documentation and visit reports.
• Collaborate with study team for project execution support.

Skills

Site monitoring

GCP/ICH knowledge

Travel flexibility

Education

Life science degree

Job description

IQVIA UK's Site Management (multi-sponsor) team is growing and seeking junior and experienced Clinical Research 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, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• 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
• You have 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
• Please note - this role is not eligible for UK visa sponsorship

Summary

Location: Manchester, England, United Kingdom; Leeds, West Yorkshire, United Kingdom; Reading, Berkshire, United Kingdom; London, United Kingdom; Type: Full time

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.