Senior CRA Australia — Remote Lead for Global Trials

Worldwide; Melbourne; Hybrid; AUD 90,000 - 130,000; Full time

Job summary

Worldwide Clinical Trials in Australia seeks a Senior Clinical Research Associate to lead site qualification, initiation and interim monitoring visits, and manage study close-out activities in line with GCP and SOPs.

You will ensure data quality, timely safety reporting, and mentor less experienced CRAs and site staff. Strong knowledge of FDA/EU guidelines and IxRS/EDC tools is required for this senior role.

Qualifications

• MD or Pharmacist degree required or equivalent
• Minimum CRA experience: 3+ years (if MD/Pharm path) or 5+ years (other path)
• Willingness to travel and valid passport
• Fluent in English, local regulatory knowledge

Responsibilities

• Perform feasibility studies for potential sites
• Conduct pre-study, initiation and interim monitoring visits as per protocol
• Lead CRA for global studies and coordinate team activities
• Mentor junior CRAs and site staff when needed
• Develop Clinical Monitoring Plan and study tools
• Review regulatory documents and TMF readiness
• Ensure safety reporting and data query resolution

Skills

Communication

Planning & organization

Interpersonal skills

Initiative & problem solving

Leadership (lead CRA)

Study monitoring

IxRS/EDC proficiency

MS Office

Education

MD or Pharmacist degree

Nursing degree (preferred)

Tools

IxRS

EDC systems

Microsoft Office

Job description

Worldwide Clinical Trials in Australia seeks a Senior Clinical Research Associate to lead site qualification, initiation and interim monitoring visits, and manage study close-out activities in line with GCP and SOPs.

You will ensure data quality, timely safety reporting, and mentor less experienced CRAs and site staff. Strong knowledge of FDA/EU guidelines and IxRS/EDC tools is required for this senior role.