Melbourne, Australia | Full time | Hybrid | R1543275
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 workplace
* Proficiency in Microsoft Office
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