Clinical Research Associate

Job Description

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 (BCT) 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 47years, our committed team of breast cancer specialists has been focused on one thing: the well-being of those affected by breast cancer.

\n

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 a CRA starting within our Clinical Operations Stream. The Clinical Operations stream is responsible for the effective conduct and ongoing coordination of each clinical trial undertaken by BCT trial sites.

\n

What You'll Be Doing:

\n

\n
• Coordinate site initiation activities once all pre-activation requirements have been met.
\n
• In collaboration with other Trials Department teams, manage the progress of assigned trials including, but not limited to:
\n
• TMF maintenance and tracking including Quality Assurance of essential site documentation,
\n
• recruitment and enrolment,
\n
• data quality and timeliness (Case Report Form (CRF) completion/ submission, data query generation/resolution)
\n
• safety reporting including adverse events (AE's and SAE's)
\n
• Ensuring any identified deviations/breaches have been reported appropriately, ensuring appropriate corrective and preventative actions are implemented and required ethics and regulatory reporting requirements.
\n
• Administer protocol to assigned sites and establish regular lines of communication to manage ongoing project expectations, enquiries and issues.
\n
• Create and maintain appropriate documentation regarding site management.
\n
• Perform Site Initiation, Monitoring and Close-out visits in accordance with monitoring plan, contracted scope of work and good clinical practice.
\n
• Assist with the coordination of routine trial committee meetings (teleconference and face-to-face) and communication activities according to the trial specific communication plans.
\n
• Manage trial medication supply in liaison with institutional pharmacies and vendor/suppliers.
\n
• Manage pathology collection and shipping in liaison with institutions, shipping vendors and central pathology processing vendors.
\n
• Attendance at trial specific meetings both internal and external to ensure a coordinated approach to activation and coordination of each trial
\n
• Upholding the highest standards as per study protocols and ICH GCP guidelines.
\n

\n

Is This You?

\n

\n
• A background in Science, Clinical/Life Sciences, Nursing, Health, or Research.
\n
• Clinical research experience, preferably as a CRA with monitoring experience would be viewed favourably, but we value passion over experience.
\n
• Strong organizational and problem-solving acumen.
\n
• Nimbleness to adapt to shifts and new opportunities.
\n
• Dependable adherenceto processes and guidelines.
\n
• Proficient in digital tools and clinical trial management systems.
\n
• Willingness to travel occasionally within Australia and to New Zealand.
\n
• Excellent oral and written communication skills
\n

\n

Work Location and Other Benefits:

\n

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. And of course, we will let you have all of the other employment benefits too.

\n

Ready for a Refreshing Change?

\n

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,