PSI CRO AG
PSI CRO AG
PSI CRO AG — клиникалық зерттеулерді қолдайтын, негізгі мәні бар 2 және 3-кезеңдегі зерттеулерге басымдық беретін жаһандық келісімшарттық зерттеу ұйымы. Компанияның қызметі ішектің қабыну аурулары, онкология, гематология, инфекциялық аурулар, шашыраңқы склероз және сирек кездесетін ауруларды қоса алғанда, әртүрлі терапиялық бағыттарды қамтиды. PSI CRO AG клиникалық зерттеулерді жоспарлау және қаржылық бақылау үшін меншікті платформаны пайдаланады, бұл командаларға зерттеу мерзімдері мен бюджеттерді бақылауға көмектеседі. Компанияның бейіні денсаулық сақтау және консалтинг салаларындағы тәжірибені сапаға, үйлесімділікке және зерттеулерді сенімді түрде жүргізуге басымдық берумен ұштастырады.

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.

Сипаттама

  • 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

Талаптар

  • 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

Артықшылықтар

  • 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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