CRA2 - Multi-Sponsor Department

IQVIA

Manchester

On-site

GBP 32,000 - 52,000

Full time

3 days ago
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Job summary

IQVIA UK is seeking junior and experienced Clinical Research Associates for its Site Management team in Manchester. You will perform on-site monitoring visits, ensure GCP/ICH compliance, and liaise with clinical sites to support study requirements.

The role requires travel, strong documentation, and collaboration with study teams to manage recruitment, data queries, and regulatory submissions across multiple sites.

Qualifications

  • Experience of independent on-site monitoring.
  • Managed multiple clinical trial protocols across diverse sites.
  • Strong knowledge of GCP/ICH guidelines.
  • Life science degree or equivalent industry experience.
  • Willingness to travel to sites.

Responsibilities

  • Perform site monitoring visits (selection, initiation, monitoring and close-out) per contracted scope and regulatory requirements (GCP/ICH).
  • Drive subject recruitment plans to align with project needs.
  • Administer protocol training and maintain regular communication with sites.
  • Evaluate site practices for protocol conduct and regulatory adherence.
  • Track regulatory submissions, recruitment and enrollment, CRF completion and data query resolution; may support start-up.
  • Ensure TMF/ISF documentation is maintained and visit reports are generated.
  • Collaborate with study team members for project execution support.

Skills

On-site monitoring
Multiple trials
GCP/ICH knowledge
Travel flexibility
Site communication
Regulatory tracking

Education

Life science degree

Job description

IQVIA UK's Site Management (multi-sponsor) team is growing and seeking junior and experienced Clinical Research Associates.

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

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 https://jobs.iqvia.com

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.

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