Cctc Quality Lead

2 weeks ago

Melbourne, Victoria, Australia Austin Health Full time

Location:
Melbourne | Northern Metropolitan

Job type:
Full time, Part time

Organisation:
Austin Health

Salary:
Salary not specified

Occupation:
Administration/Secretarial, Human Resources, Legal, Occupational Health and Safety, Medical, Nursing

Reference: 51355

Seeking Cancer Clinical Trials Quality Lead to work in Austin Cancer Clinical Trials Centre

  • Full time (40yrs with ADO), or less by negotiation fixed term 12 month contract.
  • Make a difference supporting quality assurance and leading quality improvement activities within CCTC.


Austin Health is the major provider of tertiary health services, health professional education and research across three campuses in the north-east of Melbourne and state-wide.

We have a highly engaged, diverse and collaborative workforce that is unified by our purpose, which is to help people live healthy and fulfilled lives.


About the Austin Cancer Clinical Trials Centre (CCTC)


Austin Health's CCTC has a reputation of excellence with expertise in managing clinical trials from First-in-human Phase 1 to Phase 3.

We have over 200 clinical trials in progress including Pharmaceutical Company sponsored, Collaborative Group and Investigator-initiated trials.

About the role


The successful applicant will become part of an established tumour stream team, led by a Team Leader and will be responsible for the primary coordination of clinical trials and the management of patients on those trials.

The role involves delivery of direct and in-direct clinical-trial-related care of patients, associated data collection and maintenance of essential trial documents for concurrent studies.


A regular day will see you:

  • Lead initiatives aligned to NSQHSS, in particular the National Clinical Trials Governance Framework to drive CCTC practice improvement.
  • In consultation with the CCTC Manager, supervise Corrective Action/Preventative Action (CAPA) process across the department.
  • Facilitate audit and/or regulatory inspections, supporting staff with audit preparations.
  • Ongoing review and enhancement of orientation, training material, support, and competencies for new and existing Trial Coordinators.
  • In collaboration with the CCTC Manager assist in improving efficiencies within clinical operations, including development, review and oversight of SOPs and implementation of risk evaluation and mitigation processes for clinical studies.

About you
To be successful in this role you'll bring with you:

  • Registered Nurse (Division 1) with current AHPRA registration OR Relevant Health Sciences Background.
  • Extensive site experience in Clinical Trials Research including direct clinical trial coordination.
  • Direct audit/inspection experience
  • Demonstrated excellent understanding of the quality requirements for clinical trial coordination and trial related clinical care.
  • A background of experience which enables excellent competencies and skills for the management of clinical trials and staff coordinating trials.
  • Demonstrated expertise in communicating and liaising effectively with a range of personnel, key stakeholders, and organisations.

Our benefits
Working at Austin Health means enjoying a strong sense of purpose, engaging in meaningful work every day.

Our people also receive a variety of rewarding benefits, including:

- $11,660 in salary packaging benefits, for living expenses, meals and holiday accommodation

  • A suite of wellness initiatives designed to support you, including discounted fitness memberships and special offers on health insurance, and a comprehensive wellbeing program
  • Mentoring, learning and career development opportunities
  • Onsite childcare, easy access via public transport, discounted car parking and end of journey facilities for cyclists
  • Five weeks annual leave

Inclusion at Austin
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