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PSI CRO AG
PSI CRO AG
1.001 – 5.000 Angajați
Asistență medicalăConsultanțăLogistică
PSI CRO AG este o organizație globală de cercetare contractuală care sprijină studiile clinice, cu accent pe studiile esențiale de fază 2 și fază 3. Activitatea sa acoperă domenii terapeutice precum bolile inflamatorii intestinale, oncologia, hematologia, bolile infecțioase, scleroza multiplă și bolile rare. Compania utilizează o platformă proprie pentru planificarea studiilor clinice și monitorizarea financiară, ajutând echipele să urmărească termenele și bugetele studiilor. Profilul PSI CRO AG combină expertiza în domeniul sănătății și consultanței, punând accent pe calitate, compatibilitate și desfășurarea fiabilă a studiilor.
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Locurile de muncă ale companiei

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.

AUAustraliaRemoteNormă întreagăSeniorLimbă Obligatorie: englezăCercetare clinică

Descriere

  • 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

Cerințe

  • 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

Beneficii

  • 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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