Contract Senior CRA – Australia

Planet Pharma; Australia; Hybrid; AUD 90,000 - 150,000; Full time

Job summary

Planet Pharma is seeking a Contract Senior Clinical Research Associate to oversee clinical trials in neuro, rare disease, and other specialty areas. This remote-or-onsite role offers a flexible contract through March 2027 across Australia, supporting multiple studies with emphasis on data integrity and patient safety.

Ideal candidates have 4+ years as a CRA, strong regulatory knowledge, and the ability to work independently.

Qualifications

• Minimum 4 years’ CRA experience in clinical trials.
• Experience monitoring complex or global trials.
• Knowledge of FDA, EU, ISO14155 regulations and monitoring procedures.
• Ability to work independently, plan effectively, and prioritize tasks.
• Current working rights in Australia.

Responsibilities

• Conduct remote, onsite, or hybrid monitoring visits per protocols.
• Deliver monitoring reports for sponsor approval, ensuring data quality and integrity.
• Plan daily activities, prioritize sites, and support study startup, interim, and close-out visits.
• Maintain and review Trial Master Files and electronic documentation.
• Collaborate with study teams to identify and address quality issues and escalate as needed.
• Support data quality, patient safety, and adherence to regulatory standards.

Skills

Clinical trial monitoring

Regulatory knowledge (FDA/EU/ISO14155)

Independent work planning

Remote/onsite adaptability

ICH GCP compliance

Education

Undergraduate degree or equivalent in clinical, science, or health-related field

Tools

Clinical trial systems

Web-based tools for communication

Job description

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 environment. If you’re ready to make an impact and grow your expertise, we want to hear from you.