12 Oct
|
Planet Pharma
|
City of Wollongong
12 Oct
Planet Pharma
City of Wollongong
Join our team as a Contract Senior Clinical Research Associate and be part of groundbreaking efforts to bring life-changing medical innovations to patients worldwide. If you're passionate about advancing healthcare and thrive in a collaborative, dynamic environment, this is your chance to make a meaningful impact while developing your career.
Overview
As a Senior CRA, you'll play a vital role in overseeing clinical trials that contribute to critical advancements in neuro, rare disease, and other specialty areas. Operating within a flexible contract until March 2027, you will work remotely or onsite across Australia, supporting multiple studies and ensuring the highest standards of data integrity and patient safety.
What You’ll Do
- Conduct remote, onsite, or hybrid monitoring visits, ensuring compliance with clinical trial protocols, ICH GCP, and local regulations.
- Deliver high-quality, timely monitoring reports for sponsor approval, maintaining accuracy and completeness of clinical data.
- Plan daily activities, prioritize sites, and support study startup, interim, and close-out visits.
- Maintain and review Trial Master Files and electronic documentation, verifying essential documents are accurate and current.
- Collaborate with study teams to identify and address quality issues,
escalating concerns as needed to ensure smooth trial progress.
- Contribute to the overall success of clinical studies by supporting data quality, patient safety, and adherence to regulatory standards.
Must-Have Requirements
- Undergraduate degree or equivalent in clinical, science, or health-related field; or relevant work experience.
- Minimum of 4 years’ experience as a CRA with a solid background in clinical trials.
- Proven experience monitoring complex or global trials.
- Knowledge of FDA, EU, ISO14155 regulations, and clinical monitoring procedures.
- Ability to work independently, plan effectively, and prioritize tasks.
- Current working rights in Australia.
Nice-to-Have Skills
- Experience coaching or mentoring other CRAs.
- International or global monitoring experience.
- Familiarity with web-based communication tools and clinical systems.
- Background in neuro or rare disease studies is highly desirable.
This contract offers an exciting opportunity to contribute to innovative medical research in a supportive and inclusive workplace. If you’re ready to make an impact and grow your expertise, we want to hear from you.
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📌 Contract Senior CRA - Australia (City of Wollongong)
🏢 Planet Pharma
📍 City of Wollongong