PSI CRO AG
PSI CRO AG
1,001 – 5,000 Employees
ConsultingHealthcareLogistics
PSI CRO AG is a global contract research organization supporting clinical trials, with a focus on pivotal Phase 2 and Phase 3 studies. Its work spans therapeutic areas including inflammatory bowel disease, oncology, hematology, infectious diseases, multiple sclerosis, and rare diseases. The company uses a proprietary platform for clinical trial planning and financial tracking, helping teams monitor study timelines and budgets. PSI CRO AG’s profile combines healthcare and consulting expertise with an emphasis on quality, compatibility, and reliable trial delivery.

Senior Clinical Research Associate – Australia (Remote)

Lead clinical research activities for PSI CRO’s Australian trials, supporting site monitoring, stakeholder communication, participant safety, and data quality. This senior role covers complex studies, investigator training, audits, and regulatory documentation.

Description

  • Oversee clinical activities for full-service global projects in Australia
  • Serve as a primary point of contact for project stakeholders
  • Keep clinical research projects aligned with timelines, targets, and quality standards
  • Develop and sustain effective relationships with clinical sites and investigators
  • Safeguard participant rights, safety, and well-being while maintaining data quality and compliance
  • Train, mentor, and supervise junior CRAs on study-level responsibilities
  • Plan, conduct, and document selection, initiation, routine, and closeout monitoring visits
  • Provide training for investigators, site personnel, and project teams
  • Contribute to complex clinical studies
  • Review CRFs, verify source documents, and resolve queries
  • Coordinate communication with clinical sites
  • Support site identification and feasibility activities
  • Create and present materials for Investigator Meetings
  • Prepare for company audits, attend them, and address resulting findings
  • Assist Regulatory Affairs with obtaining site regulatory documentation
  • Keep study-specific automated tracking systems up to date

Requirements

  • A college or university degree in Life Sciences, or an equivalent combination of education, training, and experience
  • At least four years of independent on-site monitoring experience in Australia
  • Experience conducting all types of monitoring visits in Phase II and/or Phase III studies
  • Willingness and availability to travel
  • Experience in inflammatory bowel disease, oncology, or infectious diseases is advantageous
  • Proficiency with Microsoft Office applications
  • Ability to plan effectively and work in a dynamic team environment
  • Strong communication, collaboration, and problem-solving abilities

Benefits

  • Competitive salary
  • Hybrid work arrangement with two flexible days and three office days for Sydney-based employees
  • Access to an on-site gym for Sydney-based employees
  • Five additional wellness leave days
  • Professional development and learning opportunities
  • Opportunity to contribute to a meaningful industry
  • Ongoing support from colleagues around the world
  • Practical learning through on-the-job experiences
  • Formal development programs
  • A range of opportunities for continued career growth

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