Clinical Research Associate II

Premier Research Group; Australia; Hybride; AUD 90 000 - 120 000; Plein temps

Résumé du poste

Premier Research Group is seeking a Clinical Research Associate II to join the Clinical Monitoring, Site Management and SSU team in Australia. The role involves monitoring activities (remote/onsite) to ensure data integrity and patient safety, and maintaining essential trial documents in line with ICH/GCP.

The successful candidate will have an undergraduate degree in a clinical/health field and CRA experience, with working rights for Australia.

Qualifications

• Undergraduate degree or equivalent in clinical/health field.
• Previous CRA experience required.

Responsabilités

• Deliver monitoring reports for sponsor approval per timelines.
• Submit travel expenses per company guidelines.
• Monitor data integrity and patient safety per country regulations.
• Plan day-to-day activities for site monitoring and set priorities.
• Prepare for and conduct on-site visits (qualification, initiation, interim, close-out).
• Maintain TMF/eTMF per filing guidelines and update essential documents per ICH/GCP.

Connaissances

Clinical Monitoring

Data integrity

Regulatory knowledge

Site monitoring

Formation

Undergraduate degree (clinical/health)

Licensed health-care professional (e.g., RN)

Description du poste

Premier Research is looking for a Clinical Research Associate II to join our Clinical Monitoring, Site Management and SSU team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• Your ideas influence the way we work, and your voice matters here.
• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What You'll Be Doing

• 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 specific country regulations
• Plan day-to-day activities for monitoring of a clinical study and sets priorities per site
• Prepare for and conducts on-site qualification, study initiation, interim monitoring, and close-out monitoring visits at investigator sites as required by clinical monitoring plan
• Maintain Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Understand the required essential documents according to ICH/GCP Section 8. Review site documents and verifies they are accurate, complete, current, and include required updates

What We Are Searching For

• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
• Previous experience as a CRA required

This position requires current working rights for Australia.