Have you been in a relentless race, chasing unrealistic KPIs and deadlines? Perhaps it’s time for a meaningful shift. Here at Breast Cancer Trials, our mission transcends profit margins and corporate hierarchy. Breast Cancer Trials is not a CRO; we are a not-for-profit health charity conducting clinical trials research into all aspects of breast cancer diagnosis, treatment, and care. For over 45 years, our committed team of breast cancer specialists has been focused on one thing: the well-being of those affected by breast cancer.
Here, you’ll contribute to transformative national and international clinical trials, making a direct impact on lives. If you’re driven by purpose and yearn to be part of something bigger, we are offering a position for study start up and regulatory CRA within our Ethics, Regulatory and Start-Up stream. The ERSU stream is responsible for the effective set-up of each clinical trial at trial sites and accountable for reaching trial activation milestones.
What You’ll Be Doing:
* Working within the ERSU stream, contribute to the ethics and regulatory management of all BCT clinical trials through assisting with ethical applications, site contracting, and the launching of study activities.
* Be the primary contact, facilitating communication between our sites and BCT's operational teams to ensure a smooth start-up process before the study is handed to the Clinical Operational Team.
* Ensure each study’s success through the completion of start-up HREC submission and approval, site governance submission support, essential document management, and system account creation, documentation of relevant site notes, and creation of clinical site files.
* Building and maintaining communication bridges with sites to ensure smooth clinical trial operations.
* Maintaining and inputting data meticulously into our internal database and trackers.
* Streamline and continuously refine processes to ensure effective and timely start-up for every study.
* Attendance at trial-specific meetings both internal and external to ensure a coordinated approach to activation and coordination of each trial.
* Upholding the highest standards as per study protocols and ICH GCP guidelines.
Is This You?
* A background in Science, Clinical/Life Sciences, Nursing, Health, or Research.
* Clinical research experience, preferably in study start-up or regulatory management would be viewed favourably, but we value passion over experience.
* Strong organizational and problem-solving acumen.
* Nimbleness to adapt to shifts and new opportunities.
* Dependable adherence to processes and guidelines.
* Proficient in digital tools and clinical trial management systems.
* Willingness to travel occasionally within Australia and to New Zealand.
* Excellent oral and written communication skills.
Work Location and Other Benefits:
BCT is situated amidst the scenic views of Newcastle Harbour, offering a serene escape from the rapid pace of capital cities, letting you focus on what truly matters. We understand the value of a balanced life and provide employee benefits like health charity salary packaging, ample leave options, and personal insurance. If working in Newcastle is not for you right now, that’s ok. BCT is happy to consider remote working opportunities for the right candidate with experience as a CRA or other relevant clinical trial role.
Ready for a Refreshing Change?
Join a place where your contributions are more than just a number. Dive into a world where you’re genuinely cherished, and your work directly fuels a noble cause. If the idea of being part of a workplace that is purpose-driven resonates with you, please apply now.
To apply for this rewarding position please click ‘Apply’ and forward a current CV and covering letter addressing the above-mentioned ‘is this you’ criteria. Please note, there is no formal closing date for this role. If you are interested, please apply as soon as possible as candidates will be shortlisted and interviewed as applications are received.
Please note, applicants must be able to provide proof of vaccination against COVID-19.
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