Senior CRA — Remote APAC Clinical Trials Lead

Healthcare Professionals Group; Sydney; Remote; AUD 110,000 - 140,000; Full time

Job summary

Healthcare Professionals Group is seeking a Senior CRA to deliver high-quality clinical trials across the Asia-Pacific region, ensuring safety, ethics and efficiency while building partnerships with sites and sponsors.

In an FSP model, you will conduct site selection, initiation, monitoring and close-out visits; drive patient recruitment; train site staff; perform data checks; prepare monitoring reports and upload essential documents to the eTMF.

Qualifications

• Bachelor's degree in a scientific discipline or health care preferred.
• 4+ years independent monitoring experience.
• Proficient in ICH-GCP and local regulations.
• Understanding of the drug development process.
• Strong written, verbal, and computer skills.
• Ability to work independently in remote environments.
• Previous Senior CRA experience.

Responsibilities

• Operate in 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

Independent working

ICH-GCP knowledge

Communication skills

Drug development understanding

Education

Bachelor's degree in science/health care

Job description

Healthcare Professionals Group is seeking a Senior CRA to deliver high-quality clinical trials across the Asia-Pacific region, ensuring safety, ethics and efficiency while building partnerships with sites and sponsors.

In an FSP model, you will conduct site selection, initiation, monitoring and close-out visits; drive patient recruitment; train site staff; perform data checks; prepare monitoring reports and upload essential documents to the eTMF.