Clinical Research Associate II (Medical)

TL;DR

Clinical Research Associate II (Medical): Delivering quality clinical monitoring and site management for biotech, medtech, and pharma companies with an accent on data integrity and patient safety. Focus on conducting site visits, maintaining TMF/eTMF documentation, and ensuring compliance with ICH/GCP and country regulations.

Location: Australia (Current working rights required)

Company

hirify.global helps biotech, medtech, and specialty pharma companies transform breakthrough science into new medicines, devices, and diagnostics.

What you will do

• Deliver quality, timely monitoring reports for sponsor approval according to Clinical Monitoring Plan timelines.
• Perform monitoring (remote, onsite, or other approved modes) focusing on data integrity and patient safety.
• Plan day-to-day activities for clinical study monitoring and set priorities per site.
• Conduct on-site qualification, study initiation, interim, and close-out monitoring visits.
• Maintain Trial Master File (TMF) and electronic Trial Master File (eTMF) per organizational and ICH/GCP guidelines.
• Manage travel and expense submissions according to company guidelines.

Requirements

• Undergraduate degree in a clinical, science, or health-related field, or a licensed health-care professional (e.g., registered nurse).
• Previous professional experience as a Clinical Research Associate (CRA).
• Must possess current working rights for Australia.

Culture & Benefits

• Commitment to professional growth, providing the skills and opportunities to excel.
• Flexible work-life balance to accommodate personal needs.
• Employee-driven environment where individual ideas influence work processes.
• Opportunity to contribute to life-saving medical innovations.