Senior Clinical Research Associate

Reposted 4 Days Ago
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Reading, Berkshire, England, GBR
In-Office
Senior level
Healthtech
The Role
The Senior Clinical Research Associate will manage site monitoring visits, ensure compliance with GCP and ICH guidelines, and support project execution in clinical trials.
Summary Generated by Built In

Join Us on Our Mission to Drive Healthcare Forward

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.

Do you want to know more about IQVIA? then see what Forbes said about us!

https://www.forbes.com/sites/vijaygurbaxani/2020/11/29/cios-with-vaccines-on-the-horizon-its-time-to-accelerate/?sh=5ca3b83237a1

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

  • 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

Apply today and forge a career with greater purpose, make an impact, and never stop learning!

*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

Top Skills

Good Clinical Practice (Gcp)
International Conference On Harmonization (Ich) Guidelines
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The Company
Bangalore, Karnataka
61,500 Employees
Year Founded: 2016

What We Do

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 70,000 employees, IQVIA conducts operations in more than 100 countries. To learn more, visit www.iqvia.com.

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