Cctc Quality Lead

2 weeks ago

Melbourne, 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: 50119

**A rare and exciting opportunity to join Austin Cancer Clinical Trials based in the ONJ Centre as our Quality Lead. We are seeking a full-time employee (40hrs with ADO), however part-time may be considered on negotiation.**

**About our Centre**

Cancer Clinical Trials (CCT) within the ONJ Centre has a reputation of excellence with expertise in managing clinical trials from First-in-human Phase I to Phase 3.? We have over 200 clinical trials in progress including Pharmaceutical Company sponsored, Collaborative Group and Investigator-initiated trials. All the specialised leading-edge cancer treatment and research conducted through the ONJ Centre is complemented by wellness programs to support patients in body, mind and spirit.

**About the role**

In collaboration with the CCTC Manager, the Quality Lead will develop and maintain the department quality portfolio in accordance with Austin policies, the National Standards, and clinical research ethical and regulatory requirements.

The Quality Lead is an integral member of the leadership group and models the core values of Austin Health through effective leadership, providing opportunity for learning and development, and fostering a positive culture of success.

**Duties/Responsibilities include (but not limited to)**:

- Lead initiatives aligned to NSQHSS, in particular the National Clinical Trials Governance Framework to drive practice improvement at the local level.
- Ongoing review and development of orientation, training material, support and competencies for new and existing Trial Coordinators
- Identifying achievable and measurable quality assurance activities that align with organisational and research ethical standards.
- Ongoing evaluation of QA needs across the department
- Facilitate audit and/or regulatory inspection process including direct support and education to staff in audit preparation and audit report follow up processes.
- 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.

**Qualifications/Skills/Experience include (but not limited to)**:

- A registered Nurse with Nursing and Midwifery Board of Australia or Relevant Health Sciences Background.
- Extensive site experience in Clinical Trials management including direct clinical trial coordination.
- Demonstrated excellent understanding of the quality requirements for clinical trial coordination and trial related clinical care.
- Ability to communicate effectively in both written and verbal form, and problem solve in a variety of complex situations.
- Have a flexible, innovative team-oriented approach to service delivery
- Demonstrated leadership ability, with a clear understanding of the responsibilities of the Quality Lead role.

The atmosphere within the Cancer Clinical Trials Centre is energetic, friendly and cohesive, with a strong teamwork ethic amongst all members.

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