Clinical Research Associate II

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

## Clinical Research Associate IIApply: Remote: Australia: Full time: Posted 17 Days Ago: R7000Premier 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.**### Why Choose Premier?* Premier Research is more than a company – it’s a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems.* Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies.* As a Premier team member, you have the power to make an impact, regardless of job title and location.* Our dedication to biotech and specialty pharma is unlike any other.* We provide our staff with innovative technologies and continuous learning.