Scientia Clinical Research Ltd
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Scientia Clinical Research (SCR) is the first publicly funded purpose built early phase clinical trials centre in NSW. In addition to first time in human and first time in patient studies the facility also supports other Phase 1/2 trials across a broad range of therapeutic areas. You will work with a cross-functional team of medical, clinical, scientific, nursing, pharmacy, laboratory and data management professionals highly experienced in the early phase development of new medicines.
Qualifications & experience
- A science degree in life science or similar areas.
- At least 5 years’ experience within the pharmaceutical, biotechnology and/or CRO environment.
- At least 6 months experience in QA at a dedicated Phase 1 clinical trial centre (investigational site).
- Experience in GCP and other compliance audits and inspections as well as vendor qualification and audits
- High level knowledge of GCP and relevant aspects of other GxPs.
- Experience in electronic QMS platforms (preferably Salesforce)
- Experience in computerized system validation.
- Demonstrated leadership and team management skills.
- Excellent technical and clinical writing skills; excellent computer literacy esp. in standard MS package, eQMS and other databases.
- Excellent organizational and interpersonal skills; including the ability to competently liaise and provide feedback to internal and external collaborators and stakeholders.
Tasks & responsibilities
- Responsible for Quality and Compliance oversight of Phase 1 clinical studies and operational processes to ensure compliance with Scientia Clinical Research (SCR) policy and procedures, protocols and applicable regulatory requirements.
- Collaborate with key stakeholders to identify process gaps, areas for improvement and ensure the application of quality processes, principles and strategy to support compliance with relevant regulations, GCP guidelines, procedures and sponsor agreements.
- Develop and/or improve governance SOPs, Policies and other Quality Documents in order to streamline processes and drive compliance.
- Serve as GCP and other relevant GxP subject matter expert in the support of clinical study activities.
- Manage SCR’s eQMS ©Dot Compliance Suite and fulfil System Administrator and QA roles within.
- Host sponsor/CRO audits and inspections; manage SCR’s internal audit program and study reviews using ©Dot Compliance; and coordinate analysis of findings and ensure effective CAPA management within the required timelines.
- Manage vendor and supplier assurance, vendor audits and qualification.
- Management of Scientia’s eISF (SiteDocs) and act as mentor and trainer for relevant clinical study team members
- Manage SCR’s equipment and asset database; ensure compliance with maintenance and calibration requirements; supervise and coordinate computerised system validation activities and act as validation lead.
- Act as a Research Governance Officer and assist CEO in privacy law matters.
- A non-profit organisation offering salary packaging benefit entitlements.
- State-of-the-art facility close to the beach, shops and public transport including the light rail just in front of the building
- Work closely with national and international pharmaceutical and biotechnology stakeholders
If you would like more information about this opportunity, please contact email@example.com and quote “Quality Associate”, or apply directly online at the top of this page.
Thank you for your interest.