Experienced CRA - Single Sponsor Dedicated

IQVIA

Reading

On-site

GBP 35,000 - 52,000

Full time

2 days ago
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Job summary

IQVIA is seeking experienced Clinical Research Associates in the UK to perform on-site monitoring and drive study execution across selected sites. This role requires strong GCP/ICH knowledge, a life science background, and travel to various sites.

The position offers opportunities to work with cutting-edge medicines and contribute to pivotal clinical research efforts within a global organization. You'll collaborate with cross-functional teams to ensure quality and compliance throughout the trial

Qualifications

  • Minimum 6 months of independent on-site monitoring experience.
  • Experience managing multiple clinical trial protocols across diverse sites.
  • Strong knowledge of Good Clinical Practice (GCP) and ICH guidelines.
  • Bachelor's degree in life sciences or equivalent industry experience.
  • Willingness to travel to sites as needed.

Responsibilities

  • Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope and GCP/ICH requirements.
  • Collaborate with sites to drive subject recruitment plans for project needs.
  • Provide protocol training to sites and maintain regular communication on study outcomes.
  • Assess site practices and escalate quality issues following regulatory standards.
  • Track regulatory submissions, recruitment, CRFs, and data queries; support startup activities as needed.
  • Ensure TMF/ISF documents are filed and maintained per requirements.
  • Create reports and follow-up communications documenting visit findings and actions.
  • Liaise with the study team to support project execution.

Skills

On-site monitoring
Clinical trial management
GCP/ICH knowledge
Travel readiness
Communication skills

Education

Life science degree

Job description

Join Us on Our Mission to Drive Healthcare Forward

IQVIA cFSP (sponsor-dedicated) are seeking experienced Clinical Research Associates in the UK.

Why IQVIA?

  • IQVIA is recognized as #1 in its category on the 2025 Fortune® World’s Most Admired Companies™ list for the FOURTH consecutive year!
  • We offer genuine career development opportunities for those who want to grow as part of the organization.
  • The chance to work on cutting edge medicines at the forefront of new medicines development.
  • IQVIA has access to significant data pools allowing better site selection and recruitment. This helps drive performance of sites making the CRA role more efficient and discussions at site more productive. Next generation clinical development!
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 (minimum 6 months).
  • 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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