Remote CRA II - Impactful Trials

Premier Research Group; Australia; Remote; AUD 100,000 - 130,000; Full time

Job summary

Premier Research is seeking a Clinical Research Associate II to join our Clinical Monitoring, Site Management and SSU team. This role supports biotech, medtech, and specialty pharma companies by delivering high-quality monitoring activities for studies conducted remotely in Australia.

You will plan and perform on-site or remote monitoring visits as required, maintain TMF/eTMF documentation, and ensure data integrity and patient safety in accordance with ICH/GCP guidelines.

Qualifications

• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution.
• Licensed health-care professional (e.g., registered nurse) or equivalent work experience required.

Responsibilities

• Deliver quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines.
• Maintain submission of expenses according to travel and expense requirements within company guidelines.
• Monitor (remote, onsite, or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with country regulations.
• Plan day-to-day activities for monitoring of a clinical study and set priorities per site.
• Prepare for and conduct on-site qualification, study initiation, interim monitoring, and close-out monitoring visits at investigator sites as required.
• Maintain Trial Master File (TMF)/eTMF per filing guidelines and review site documents for accuracy and updates.

Skills

Clinical monitoring

Data integrity

Regulatory knowledge

ICH/GCP familiarity

Education

Undergraduate degree or international equivalent in clinical/science/health-related field

Job description

Premier Research is seeking a Clinical Research Associate II to join our Clinical Monitoring, Site Management and SSU team. This role supports biotech, medtech, and specialty pharma companies by delivering high-quality monitoring activities for studies conducted remotely in Australia.

You will plan and perform on-site or remote monitoring visits as required, maintain TMF/eTMF documentation, and ensure data integrity and patient safety in accordance with ICH/GCP guidelines.