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IQVIA

CRA 1 (In House, Sponsor Dedicated)

Posted 4 Days Ago
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In-Office
North Sydney, Sydney, New South Wales, AUS
Mid level
In-Office
North Sydney, Sydney, New South Wales, AUS
Mid level
The In-House Clinical Research Associate supports clinical trials by managing investigational sites, performing remote monitoring, and ensuring compliance with regulatory standards.
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Overview

As an In-House Clinical Research Associate (IHCRA) at IQVIA, you will play a key role in supporting the successful delivery of clinical trials by working closely with field-based Clinical Research Associates (CRAs) and study teams. This position offers strong exposure across site management, remote monitoring, and cross-functional collaboration, contributing directly to advancing clinical research.

You will provide centralized support to investigational sites and study teams, ensuring high-quality execution and compliance with global and local regulatory standards.

Key Responsibilities

  • Provide centralized support to CRAs in managing investigational sites and maintaining protocol and regulatory compliance
  • Perform remote monitoring activities, including review of EDC data, drug accountability logs, and study documentation
  • Maintain and update clinical trial systems (e.g., CTMS, eTMF) in line with study requirements
  • Support site start-up activities, including coordination of study supplies and documentation readiness
  • Conduct quality control of site and country-level eTMF documentation
  • Act as a key point of contact for investigational sites between on-site visits:
    • Follow up on missing documents and outstanding items
    • Track recruitment progress and site performance
    • Support resolution of data queries and data entry timelines
  • Assist CRAs in preparation and follow-up for site visits (e.g., reviewing reports, tracking systems, documentation checks)
  • Support site quality management activities, including audits, inspections, and protocol deviation follow-ups
  • Contribute to study milestone activities such as interim analysis and database lock
  • Document all site communications and study interactions accurately and in a timely manner
  • Act as back-up support to CRAs when required
  • Participate in training, mentoring, and cross-functional support activities

Requirements

  • Bachelor’s degree in Life Sciences or related field; or Registered Nurse qualification
  • 2–3 years of experience in clinical research (e.g., CTA, IHCRA, Study Coordinator)
  • Strong understanding of clinical research processes, ICH-GCP guidelines, and regulatory requirements
  • Hands-on experience with clinical systems such as EDC, CTMS, and IVRS
  • High level of attention to detail with a strong quality and compliance mindset
  • Excellent organizational, communication, and problem-solving skills
  • Ability to manage multiple priorities across studies and work independently in a matrix environment
  • Proficiency in Microsoft Office

Why IQVIA?

At IQVIA, you will be part of a global team committed to improving patient outcomes through clinical research. This role offers the opportunity to develop both technical and operational expertise while contributing to studies that make a meaningful difference.

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.

IQVIA North Sydney, New South Wales, AUS Office

8/141 Walker St, North Sydney, NSW, Australia, 2060

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