Study Start-up Specialist

2 weeks ago

Adelaide Region SA, Australia Icon Group Full time

**Research**

**Adelaide**

**Full Time**

**Icon Group**

**Study Start-Up Specialist - Icon Group**
- Support the integrity of our research operations on the ground in Adelaide
- Be part of providing patient access to national and international clinical trials across medical oncology, haematology and radiation oncology
- Permanent Full-Time (Mon-Fri), Kurralta Park, Adelaide

**About Icon Research**:
Icon offers Australia’s largest private cancer clinical trials program. We have over 140 clinical trials open for recruitment and over 750 patients currently on active trials across haematology, medical oncology and radiation oncology and conduct trials from phase I through to phase IV.

**About the role**:
We have a new Study Start-Up Specialist position, known internally as Research Governance Officer, available as a to assist with our on-site research and clinical trials programs, primarily based out of our Icon Cancer Centre in the Tennyson Centre, Kurralta Park.

Reporting to the Research Governance Manager, this role operates on a permanent full-time capacity, working during business hours Monday to Friday

The overall purpose of this position is to:

- Work closely with the Research Governance Manager and the relevant Research Site Manager/s to facilitate and drive study start-up processes leading through to study and site activation
- Ensure research start-up activities are coordinated according to Icon Group Research policies and procedures
- Act as the reference point for Icon Cancer Centre staff for ethics, research governance, contracts, budgets and regulatory issues
- Assist in the continuous improvement in research and clinical trial activities conducted at Icon Group to ensure that a high quality, professional and efficient research service is consistently provided
- Liaise with the research quality team to develop and implement quality improvement initiatives for research start-up activities
- Assist with research governance reporting to Icon Group research senior management team, research committees and other Icon Cancer Centre teams as required
- Coordinate the preparation of ethical and governance submissions in accordance with GCP and all appropriate and applicable clinical trial regulations
- Assist in the development and review of research budgets under the guidance of the Research Governance Manager and Senior Operations Manager
- Assist in the study development, start-up, and ongoing management of investigator-initiated studies

**About you**:
A collaborative individual who has the ability build professional relationships with various stakeholders in the business. You will be able to independently solve problems and efficiently manage your own workload. Exceptional attention to detail and effective written and verbal communication skills are key.

**Mandatory requirements**:

- Bachelor’s degree in relevant health sciences OR other allied health field OR significant practical and professional experience in the ethics, research governance and regulatory environment
- Minimum 2 years experience in clinical research
- Understanding of national and international research guidelines, including high level knowledge of Good Clinical Practice

**How to apply?

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