Senior Clinical Research Associate

IQVIA LLC

Langley

On-site

GBP 32,000 - 52,000

Full time

6 days ago
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Job summary

IQVIA is hiring an experienced Clinical Research Associate in the UK to conduct on-site monitoring visits and support study execution. You will ensure adherence to GCP/ICH, manage site communications, and track regulatory submissions and data queries.

The role requires a life science degree or equivalent experience, travel flexibility, and the ability to collaborate across study teams to drive site performance and patient safety. IQVIA offers world-class training and career development.

Qualifications

  • Deep knowledge of GCP and ICH guidelines is required.
  • Experience performing site monitoring visits to protocol and regulatory standards.
  • Ability to manage multiple sites and communicate effectively.
  • Familiarity with regulatory submissions and TMF/ISF handling.
  • Travel to clinical sites as needed and appropriate for studies.

Responsibilities

  • Perform site monitoring visits in line with GCP/ICH and contracted scope.
  • Coordinate recruitment plans with sites to support study needs.
  • Administer protocol training and maintain regular site communications.
  • Evaluate site practices for protocol conduct and regulatory compliance.
  • Track submissions, enrollment, CRF completion, and data queries.
  • Maintain TMF and ISF per regulatory requirements.
  • Prepare visit reports and follow-up letters; draft action plans.
  • Collaborate with study team for project execution support.
  • Minimum 18 months of independent on-site monitoring experience.
  • Travel to sites to monitor progress and performance.

Skills

GCP knowledge
ICH guidelines
Site monitoring
Travel flexibility
Communication

Education

Life science degree or equivalent experience

Job description

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


A minimum of 18 months 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


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


With access to world-class training and professional development, we'll give you the tools you need to create the career you want.


Why IQVIA?

IQVIA is recognized as #1 in its category on the 2026 Fortune World's Most Admired Companies list for the fifth 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!, 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.

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