Clinical Research Associate

Clinical Research Associate (Christchurch)
- 2200458

**UNIVERSITY OF OTAGO CHRISTCHURCH**
**Te Whare Wānanga o Otāgo ki Ōtautahi**

**DEPARTMENT OF MEDICINE**
**Te Tari Whaiora**

**_About our team/Mō te tīma_**

The University of Otago, Christchurch is a research-intensive campus of the University of Otago and is based at the Christchurch Hospital. Our campus is the base for medical and postgraduate health education and health research in Christchurch.

The Department of Medicine at the University of Otago, Christchurch, has a mission to improve the lives of people in New Zealand through health education and research. The Department hosts some of the most productive researchers in New Zealand with particular strengths in heart health, brain research and musculoskeletal medicine.

The University of Otago, Christchurch is hosting many clinical trials in collaboration with District Health Boards across New Zealand. Trials for kidney diseases are actively underway in the fields of kidney transplantation, dialysis, and earlier stages of kidney disease. These include Health Research Council funded trials that have collectively received over $4 million in funding.

**_The role/Te mahi_**

The role of Clinical Research Associate will involve coordination of investigator-led clinical trials being conducted in New Zealand in collaboration with clinicians in Australia and the Australasian Kidney Trials Network (AKTN).

Key Responsibilities of this role include:

- Acting as a key liaison between participating site Investigators, Clinical Research Associates, the New Zealand Co-ordinating Investigator and the Trial Steering Committee/s.
- Acting as the convener of various trial committee meetings and focus groups.
- Assessing trial sites’ Good Clinical Practice (GCP) compliance across New Zealand.
- Responsibility for trial site monitoring, including on-site visits (approximately up to 2 visits per month).
- Convening and attending study initiation/training meetings nationally and internationally.
- Assisting with the preparation of ethical and other regulatory submissions.
- Ensuring the quality of data collected for studies through the development of quality control checks on the database and regular review of data accumulated.
- Developing project plans to ensure timely completion of project deliverables.
- Assisting in report writing for projects.
- Liaising with project leaders and trial committees to provide appropriate information and updates on trial progress.
- Representing the University of Otago at local, national and occasionally international forums on kidney disease and clinical trial conduct.
- Acting as an integral part of a small team in a flexible working environment
- Ensuring you are aware of and complying with legislation and University policy.

**_Your skills and experience/Kā pūkeka me kā wheako_**

To be successful in this role, key skills required are:

- A degree in a scientific, or nursing discipline with at least four (4) years subsequent relevant experience or an equivalent combination of relevant experience and/or education/training.
- Demonstrated substantial practical experience in the coordination of research projects, including site coordination and quality control, and the development of project plans and timelines.
- A comprehensive knowledge of ICH Good Clinical Practice (GCP).
- Experience with scientific report and manuscript writing.
- Exemplary time management capabilities.
- High level written and oral communication and inter-personal skills.
- Willingness to travel nationally and internationally, with overnight stays (approx. up to twice per month).
- Advanced computing skills, including sound knowledge of database and word processing packages.
- Familiarity with medical terminology.
- Knowledge of basic statistical concepts.
- Experience with grant proposal writing and submissions.

**_Further details/Pūroko_**

This is a fixed term (12 month), part time (0.6FTE, 22.5 hours) role.

For further information, please contact Jo Wilson via the contact details below.

**_Application/Tono_