IQVIA
IQVIA
IQVIA combines healthcare data analytics, advanced technology, and consulting to help organizations address complex challenges across the life sciences and healthcare sectors. Its Connected Intelligence platform brings together data and artificial intelligence to support clinical research, technology development, and the advancement of new therapies. The company’s teams work across analytics, consulting, and healthcare technology, offering opportunities connected to research, digital innovation, and efforts to improve patient outcomes.

Clinical Research Associate – Melbourne, Hybrid

Conduct site monitoring, recruitment oversight, compliance tracking, and study data management for IQVIA in Melbourne.

Description

  • Monitor and manage clinical study sites to ensure protocol, regulatory, guideline, and sponsor requirements are met.
  • Conduct site selection, initiation, monitoring, and close-out visits.
  • Implement and monitor subject recruitment plans.
  • Deliver protocol and study training to assigned sites.
  • Maintain regular site communication to manage expectations and resolve issues.
  • Assess site quality and integrity, escalating quality concerns as needed.
  • Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query resolution.
  • Support study start-up activities when required.
  • Ensure site documents are ready for Trial Master File filing and verify Investigator Site File maintenance.
  • Record site management activities, monitoring findings, and action plans in visit reports and follow-up letters.
  • Work with study team members to support project delivery.
  • Help develop site-specific subject recruitment plans when required.
  • Support site financial administration and collect invoices in line with local requirements when required.

Requirements

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

Benefits

  • Flexible hybrid working arrangement.
  • Competitive salary with car and health allowances.
  • Career development opportunities across FSO and FSP models.

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