About This Role
The Ethics Officer / Start-up Specialist oversees the essential documentation, preparation, and submission of ethics and governance applications for clinical trials. This role is crucial for ensuring regulatory compliance and efficient start-up timelines within a growing trial portfolio, and it suits a professional with an eye for detail and an understanding of GCP.
Responsibilities
- Oversee essential document collection
- Prepare and submit HREC and RGO applications
- Liaise with vendors
- Ensure regulatory compliance
- Ensure efficient and robust governance and start-up timelines of the growing trial portfolio
- Assist in the preparation and negotiation of study-specific budgets and contracts, or eSource/ISF (dependant upon applicant experience)
- Provide valuable support to the team to ensure adherence to best practice in research processes
Requirements
- Three to five years (highly proficient) clinical trial coordinator and/or start-up/ethics coordinator experience
- Demonstrated planning and workload management skills
- Ability to independently initiate the tracking, troubleshooting, and reporting of trial progress, from Site Selection to Close out
- Demonstrated experience with MS Word, Outlook, Excel, PowerPoint, and Access
- High attention to detail with excellent oral and written communication skills
- Personal confidence to liaise with a variety of health and research professionals
- Tertiary qualification in a health or science field
- Demonstrated understanding of ICH-Good Clinical Practice, regulatory, ethical, privacy, and other relevant guidelines and legislation relating to clinical trial conduct
Nice to have:
- Understanding of medical terminology (ideally oncology or haematology context)
- Experience in mentoring junior team members
Benefits
- Good work-life balance with options for remote working and flexibility
Important Details
- Employment type: full-time (expressions of interest), part-time (may be considered for the right applicant)
- Work format: onsite and offsite flexibility (must be based in WA)
Application Process
- Submit a cover letter (that details your working hours/FTE preference) and current CV via Seek
- You must demonstrate the right to work in Australia
About the Company
One Clinical Research (OCR) is a leader in conducting cancer clinical trials, specialising in pharmaceutical industry-sponsored clinical trials for patients with haematological (blood) or solid-organ cancers.
