IQVIA
IQVIA
IQVIA combină analiza datelor din domeniul sănătății, tehnologia avansată și serviciile de consultanță pentru a ajuta organizațiile să abordeze provocări complexe din sectoarele științelor vieții și al asistenței medicale. Platforma sa Connected Intelligence reunește date și inteligență artificială pentru a sprijini cercetarea clinică, dezvoltarea tehnologică și progresul unor terapii noi. Echipele companiei lucrează în domeniile analizei datelor, consultanței și tehnologiei medicale, oferind oportunități legate de cercetare, inovare digitală și eforturi de îmbunătățire a rezultatelor pentru pacienți.

Clinical Research Associate - Hybrid in Melbourne

Support clinical trial sites and study data for IQVIA in Australia. The role covers recruitment, compliance, documentation, monitoring, and trial delivery.

Descriere

  • Oversee site monitoring and management to ensure study conduct and data reporting meet protocols, regulations, guidelines, and sponsor requirements.
  • Conduct site visits across selection, initiation, monitoring, and close-out stages.
  • Implement, advance, and monitor subject recruitment plans.
  • Deliver protocol and study training to assigned sites while maintaining regular site communication.
  • Assess site practices for protocol and regulatory compliance, escalating quality concerns as needed.
  • Monitor regulatory submissions, approvals, recruitment, enrollment, CRF completion, and the creation and resolution of data queries.
  • Assist with study start-up activities when required.
  • Maintain Trial Master File documentation and confirm that Investigator Site Files are properly maintained.
  • Record site-management activities, monitoring findings, and action plans in visit reports and follow-up correspondence.
  • Work with study team members to support project delivery.
  • Help create site-specific subject recruitment plans when required.
  • Oversee site finances and collect invoices in line with local requirements when required.

Cerințe

  • Bachelor’s degree in a scientific or healthcare discipline, or an equivalent combination of education, training, and experience.
  • At least nine months of independent on-site monitoring experience.
  • Working knowledge of clinical research regulations, including GCP and ICH guidelines.
  • Working therapeutic-area and protocol knowledge gained through company training.
  • Proficiency with Microsoft Word, Excel, and PowerPoint.
  • Ability to use a laptop, iPhone, and iPad when required.
  • Strong organizational and problem-solving abilities.
  • Effective time and financial management skills.
  • Ability to build and maintain productive relationships with colleagues, managers, and clients.

Beneficii

  • Competitive salary plus car and health allowances.
  • Flexible hybrid working arrangement.
  • Career development opportunities across FSO and FSP models.
  • Opportunity to work with experienced managers across clinical trials in multiple phases.

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