Healthcare Professionals Group

Senior Clinical Research Associate

Healthcare Professionals Group View all jobs


Sydney, NSW
Permanent
Medical Research and Biosciences

Posted 21 day(s) ago

Reference: 3193413373


About the company

Join a well-established Australian CRO with a strong APAC footprint, delivering trials across multiple therapeutic areas and all phases. You'll be part of a close-knit team that values your input and invests in your development.

About the opportunity

As a Senior CRA, you'll be central to delivering high-quality clinical trials, keeping studies safe, ethical and efficient while building lasting partnerships across sites and sponsors.

Duties
  • FSP model
  • Conduct site selection, initiation, interim monitoring and close-out visits
  • Develop and drive patient recruitment plans with sites
  • Train and support site staff on study protocols and materials
  • Perform data checks in line with the Clinical Monitoring Plan
  • Resolve site issues promptly and elevate where needed
  • Follow up on quality issues as they arise
  • Prepare and finalise monitoring visit reports
  • Collect and upload essential documents to the eTMF on time
  • Support investigator selection and feasibility activities
  • Prepare sites for audits and regulatory inspections
Skills and Experience
  • Bachelor's degree in a scientific discipline or health care is preferred
  • Previous experience as a Senior CRA
  • Minimum of 4 years of independent monitoring experience
  • Excellent knowledge of ICH-GCP guidelines and local regulations
  • Understanding of the drug development process
  • Strong written, verbal, and computer skills
  • Ability to work independently in remote environments
Culture

You'll join a collaborative, high-performing team where ownership is encouraged, ideas are heard and your work makes a real difference to clinical research across Asia-Pacific.

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