PSI CRO AG
PSI CRO AG
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.

Clinical Research Associate II in Australia

Lead clinical trial monitoring and site management across Australia, supporting study start-up, regulatory submissions, data quality, and patient safety for PSI CRO AG.

Descriere

  • Conduct and document onsite monitoring visits across clinical trials
  • Support study start-up activities
  • Review case report forms, verify source data, and resolve queries
  • Coordinate site budgets and contract negotiations
  • Track study progress at the country level
  • Manage communication and ongoing relationships with clinical sites
  • Coordinate with internal support functions and external vendors
  • Update project teams on study progress and operational matters
  • Contribute to feasibility assessments and research
  • Assist regulatory colleagues with study submission documentation
  • Oversee clinical activities for full-service global projects in Australia
  • Maintain study timelines, targets, and applicable clinical research standards
  • Develop productive relationships with investigators and research sites
  • Protect participant rights, safety, and well-being while maintaining data quality and compliance

Cerințe

  • Degree in life sciences, pharmacy, nursing, or a comparable combination of education, training, and experience
  • At least two years of independent onsite monitoring experience in Australia
  • Experience conducting Phase II and/or Phase III monitoring visits
  • Background in inflammatory bowel disease, oncology, or infectious diseases is advantageous
  • Professional working proficiency in English
  • Working knowledge of Microsoft Word, Excel, and PowerPoint
  • Strong planning and multitasking abilities in a dynamic team setting
  • Effective communication, collaboration, and problem-solving skills
  • Willingness and ability to travel

Beneficii

  • Competitive compensation
  • Hybrid schedule with two flexible days and three office days
  • Access to an onsite gym
  • Five additional wellness-leave days
  • Professional development and learning opportunities
  • Opportunity to contribute to the clinical research industry
  • Ongoing support from colleagues worldwide
  • Practical learning through day-to-day work
  • Structured development programs
  • Multiple paths for continued career growth

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