Position Overview

The Queensland Research Centre for Peripheral Vascular Disease (QRC-PVD) within the College of Medicine and Dentistry is recognized for its research on a variety of peripheral vascular diseases. The QRC-PVD directs an increasing number of investigator-led and industry based clinical trials. The Clinical Trial Coordinator will assist in the establishment and operation of clinical trials and coordinate their successful completion as directed by the Senior Clinical Trial Coordinator and/or the Head of QRC-PVD.

Division of Tropical Health and Medicine

The Division of Tropical Health and Medicine encompasses human and animal health professional areas and related biomedical science disciplines. The Division has a particular focus on the health of rural, remote and Indigenous Australian communities and tropical medicine.

The Colleges of the Division include:

• Medicine and Dentistry
• Healthcare Sciences
• Public Health, Medical and Veterinary Sciences

College of Medicine and Dentistry

As part of the Division of Tropical Health and Medicine the College of Medicine and Dentistry promotes, fosters, supports and administers quality teaching and research at JCU in the areas of Medicine, Dentistry and Pharmacy, with a focus on the needs of rural, remote and underserved communities, tropical medicine and the health of Aboriginal peoples and Torres Strait Islanders. Working in a collaborative leadership model with the Office of the Division, the other Colleges and the Mount Isa Centre for Rural and Remote Health, the College of Medicine and Dentistry contributes to advancing the strategic agenda and to strengthening partnerships and engagement.

Organisational Charts

James Cook University

Principal Accountabilities

1. Provide high level advice to all clinical research group teams on legislation and Good Clinical Practice Guidelines, including ethics in patient based clinical research. Keep abreast of protocols and communicate changes with the clinical research groups at various sites to ensure compliance. 
2. Monitor all aspects of study site activity including maintenance of study files and liaison with other study centres.
3. Accurately complete all clinical trial paperwork including ethics forms, site specific assessments, clinical trial agreements, reporting, and registry management.
4. Liaise with external agencies (e.g. Queensland Health, pharmacists, external clinical trial centres, blood pathology centres) to ensure appropriate processes to facilitate clinical research.
5. Recruit patients to, and assess participants for clinical studies and trials, collect accurate outcome data, monitor data quality and implement data management procedures, including the use of appropriate software and requirements under the various research contracts.
6. Plan and manage meetings across the clinical trials research team to meet the requirements of each specific project and maintain effective communication. 
7. Manage the procurement and storage of all clinical trials supplies in line with JCU policies and procedures, maintaining workplace health and safety requirements and ethics and confidentiality matters.
8. The incumbent is expected to work mostly independently, dealing with many issues directly including research project logistics and stakeholder/participant queries.
9. Support the University's commitment to the principles of reconciliation, which exemplify respect for Aboriginal and Torres Strait Islander heritage and the valuing of justice and equity for all Australians.
10. Demonstrate a commitment to the University values.
11. Support the principles of the TropEco program and engage in commitment to JCU sustainability goals and objectives.

Descriptors

Professional and Technical

Level 6

Generic Accountabilities

There are generic responsibilities that apply to all James Cook University staff.  

1. The Clinical Trial Coordinator is required to observe the lawful and reasonable directions, policies and decisions of the University Council, understand and comply with the Enterprise Agreement, the Statutes and Rules of the University, the policies and decisions of the University Council and other appropriate University authorities, as in force from time to time.
2. The Clinical Trial Coordinator is required to demonstrate a personal commitment to ensure personal safety and the safety of others and contribute to the continuous improvement of our WHS performance. This includes the effective implementation and compliance with James Cook University WHS policies, procedures and safe systems of work, together with all relevant legislation, duties and obligations. Contribute to the continuous improvement of our WHS performance. 
3. The Clinical Trial Coordinator is required to exercise proper discretion in all matters affecting the well-being of the University which involve public writing or speaking in accordance with the University’s Code of Conduct.

Selection Criteria 

Selection and appointments will be assessed against selection criteria.

Essential

1. Completion of a relevant degree with subsequent relevant work experience, or an equivalent combination of relevant experience and /or education/training.
2. At least two years’ experience in the coordination of clinical trials including patient recruitment and follow-up.
3. Experience in preparing, submitting and amending human ethics and site approval applications.
4. Understanding of Good Clinical Practice Guidelines, including ethics issues in patient based clinical research and clinical research across teams in various sites.
5. High level communication and interpersonal skills, with the ability to communicate effectively and confidently with people from a variety of backgrounds. 
6. High level organisational and time management skills; ability to work largely unsupervised and respond to competing priorities.
7. Demonstrated ability to draft and review reports for the dissemination of research outcomes. 
8. Advanced knowledge of the Microsoft Office Suite (specifically Excel, Word, PowerPoint and Access) and Windows operating systems and extensive experience in using WWW browsers and common e-mail systems.  Experience with, or ability to quickly gain competency with, data management software packages.

Desirable

1. Knowledge of the Australian health system.
2. A higher degree in research methods or research related administration or similar.
3. Demonstrated empathy and respect for Aboriginal and Torres Strait islander culture.