Cancer Care Foundation (CCF) was established in 2018 as a not-for-profit charity organisation dedicated to one clear purpose - creating the much-needed practical support for cancer patients to ease and improve their treatment journey so their energies are focused on getting well.
CCF manages clinical trials at multiple centres across Australia, with our Head Office located in Miranda NSW. Due to the growth of our clinical trials business in Wollongong, CCF requires a Start-Up Specialist who will be responsible for executing clinical trial start up activities from site selection through site activation. All activities will be performed in accordance with the study protocol, company Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements.
Key responsibilities;
* Develop and manage site start-up timelines for HREC submissions and site activation.
* Proactively identify any potential delays to HREC submission or approval and any tasks critical to site activation.
* Manage local and central HREC, TGA, and registry requirements.
* Serve as primary contact with the Principal Investigator, Head of Clinical Trials, and study sponsor during study start-up.
* Negotiate site-level study budgets.
* Negotiate Clinical Trial Research Agreements (CTRA).
* Update study finance tracker based on approved CTRA.
* Edit study materials to make them site-specific e.g. Informed Consent Forms.
* Provide ad-hoc support post site-activation e.g. protocol amendment submissions to HREC.
* Other duties may be assigned as deemed appropriate.
Suitable candidates:
* A tertiary qualification in medical, life sciences, nursing, or a related field is preferred.
* A minimum of 1+ years of clinical trials experience is required, ideally in a role involving study start-up responsibilities.
* Familiarity with HREC and governance processes and competence in preparing and submitting trial documentation, preferably with Bellberry.
* Strong interpersonal and communication skills, with the ability to collaborate effectively with a broad range of stakeholders within a multidisciplinary environment.
* Excellent planning, organisational, and time management skills, with a professional, reliable, and punctual approach to work.
* Ability to adapt to changing work conditions and business needs to meet project deadlines, both autonomously and supporting colleagues.
* A high level of ownership and accountability for start-up timelines, with the initiative to resolve issues and find solutions.
* Australian work rights are required for this position.
* Police Check for employment is required.
Advantages of working at CCF:
* 5 weeks annual leave entitlement
* Salary packaging allowing up to $15,000 tax free income
* Supportive work environment where your ideas are valued and encouraged
* Career progression opportunities.