AddressThe Opportunity
Recce Pharmaceuticals is an ASX and FSE listed biotech company built on a foundation of good people and great science. There is an exciting opportunity to join the Clinical Trials Team in the Research & Development Office, supporting the expanding Clinical Trials program of Recce’s internationally recognised new class of synthetic anti-infectives.
This role will present you with the opportunity to use your skills and knowledge to contribute to all areas of the business.
The Position
Reporting to the Clinical Programs Manager in the Chief Scientific Officer's Department, you will be a primary link between Senior Management and external organisations, responsible :
- Acting as key contact to ensure that studies are conducted and documented per guidelines and local/global regulatory requirements.
- Providing support to the clinical and scientific staff.
- Participating in global research team meetings and providing reports on progress and issues requiring resolution.
- Coordinating collaborative and investigator-initiated research projects (start-up and progress through to completion) aligned with commercial objectives.
- Building and maintaining strong external and internal stakeholder relationships.
- Assisting in the planning and development of procedures and protocols.
- Site monitoring which may include travel (domestic and or international as required).
- Working collaboratively with the broader organisation for finance, legal and other project-related activities.
- Maintaining study files, documentation, and research databases to good practice and required regulatory standards where applicable.
Essential Criteria
- Minimum 2-3 years experience as a CRA or similar experience.
- Tertiary qualifications in a clinical or life sciences related field (relevant experience/qualifications in similar professions may also be considered).
- Prior experience or knowledge of audit and quality assurance activities and/or monitoring in the context of scientific studies.
- Advanced oral, written, and interpersonal communication skills to enable engagement with a variety of stakeholders.
- Demonstrated initiative and ability to work effectively autonomously and within a team environment.
- Proven proficiency in the use of the Microsoft Office suite including Word, Excel, PowerPoint, and Outlook, as well as database applications and ability to learn new systems.
- Ability to adapt to a fast-paced environment and is flexible with work hours for a global team.
- Well-developed organisational and problem-solving skills to ensure smooth workflow and meeting deadlines.
- Extensive knowledge of Australian and New Zealand drug development process, clinical trial monitoring procedures, GCP guidelines, and medical terminology are essential.
- Experience in preparation of regulatory submissions and correspondence, and safety reporting.
- Monitoring all aspects of studies to ensure compliance with GCP, study protocol and regulatory requirements, and preparation of monitoring reports.
- Biomedical research laboratory experience preferable but not essential.
- Chemistry research or testing laboratory experience preferable but not essential.
- Knowledge and or experience with FDA and EU regulatory guidelines preferable but not essential.
This is a permanent full-time position based at either our Sydney CBD Head Office or at our Bentley facility in Perth, WA with some travel required.
If you are interested in applying for this position, please include a CV and cover letter addressing the criteria with your application.
Full Australian working rights required
Applications close on Friday, 31 May 2024
No agencies please.
