Role Statement

Salary Level: Classification Level 8 (Salary range A$95,525 to A$108,186 gross per annum plus up to 17% employer superannuation contributions).
Appointment: Full-time, fixed-term (approx 3 year duration)

USC Vision

USC will be a university of international standing and an unsurpassed community asset, focusing on the region from Moreton Bay to Fraser Coast.

University Strategic Goals

The University will be:

1. a primary engine of capacity building for our region;
2. a comprehensive multi-campus university growing towards 35,000 students; and
3. positioned globally as a top-500 university, and a top-100 university under 50 years of age.

Overview of Clinical Trials Centre

USC has established a world class Clinical Trials Centre which builds the region’s collective clinical research capacity and delivers innovative and regionally relevant research in consultation with key stakeholders, including local healthcare professionals, pharmaceutical executives, and other key thought leaders. 

Overview of the Role

Under the broad direction of the Director and Clinical Trials Operations Manager, the Senior Clinical Trials Coordinator (SCTC) manages the implementation and conduct of clinical research in accordance with the appropriate quality standards including ICH/GCP, USC CTC SOPs, and applicable regulations, rules and guidance. The key focus of this role is to function in the capacity of Lead Coordinator of designated clinical trials within the USC Clinical Trials Centre (USC CTC). The SCTC will work collaboratively with the USC CTC team, sponsors, and monitors to ensure the successful conduct and timely completion of clinical trials.

Key Accountabilities

• In collaboration with the Principal Investigator provide high-level clinical research expertise to manage assigned research studies including: study start-up, HREC submission, recruitment, screening and enrolment of research subjects, development and institution of mechanisms to maximise subject adherence to the research protocol, data collection and reporting, study drug/device accountability, monitoring of participants, and education of investigators and other health care professionals, research subjects and their families and communications with the research team, as well as research and clinical leaders.
• Function as the Lead Coordinator of multiple clinical trials simultaneously and manage multiple Principal Investigator relationships, ensuring full compliance with local, state and federal policies and procedures.
• Serve as the liaison with the sponsor for assigned studies.
• Provide high-level administrative support for designated research projects and programs, including maintaining/using relevant information systems, databases and record-keeping systems
• Support the orientation and training of new Clinical Trial Coordinators.
• Contribute to the planning, management and effective implementation of continuous improvement activities relating to relevant practices, protocols, quality assurance standards and customer service excellence

The successful candidate will hold a tertiary qualification in Health Science/Bio-Medicine or similar education/training and experience.  Registered Nurse applicants must have current registration with AHPRA as a Registered Nurse and meet the NMBA professional standards. 

Applicants must demonstrate the following knowledge and skills:

• Previous Clinical Trial Coordination/Clinical Research experience.
• Nursing applicants with therapeutic expertise will be highly regarded.
• Demonstrated experience, expertise and broad knowledge in ethics/regulatory affairs frameworks.
• Detailed knowledge of clinical research practices, including an understanding of the contractual and ethical obligations of clinical trials, and ICH Good Clinical Practice.
• High level computing skills (including databases, clinical trial electronic data entry, word processing and spreadsheets).
• Sound understanding of privacy principals governing health information.
• Ability to work independently and as part of a multidisciplinary team.
• Ability to be flexible to travel to differing site locations.

Additionally, in accordance with the University’s Staff Code of Conduct – Governing Policy, all staff are expected to display professional behaviour, communicate respectfully, and perform their duties responsibly.

A role statement is not intended to limit the scope of a role but to highlight the key aspects of the role. The requirements of the role may be altered to meet the changing operational needs of the University.

Contact for Further Information

Georgina Street
Clinical Trials Operations Manager
Clinical Trials Centre

Tel: +61 7 5456 3798

Email: gstreet@usc.edu.au

Closing Date

Midnight, Monday 18 February 2019

To Apply

All applicants MUST provide both a statement of claims and resume/curriculum vitae. 

Information regarding how to prepare your application and write an effective statement of claims is available on our website information for applicants

As part of your role, you may be required to travel to any one of USC's locations.

To apply please click the Apply button at top of screen.

USC values diversity, enables access and promotes inclusion.

USC strongly encourages applications from Aboriginal and Torres Strait Islander people.