Quality Assurance Associate

Direct message the job poster from Scientia Clinical Research

Be Part of Groundbreaking Medical Research – Join Scientia Clinical Research as a Quality Assurance Associate.

Are you ready to make a meaningful impact in the advancement of new medical treatments? Join Scientia Clinical Research (SCR)—a leading, not-for-profit clinical trials facility at the heart of Sydney's health and research hub. This is your opportunity to work alongside some of the best in the field and contribute to early phase trials that shape the future of healthcare.

Why Join Us

• Work at a world-class facility: Our purpose-built, early phase clinical research centre is located in the state-of-the-art Bright Alliance Building in Randwick, alongside the Nelune Comprehensive Cancer Centre and Sydney Children's Hospital.
• Collaborate with a multidisciplinary team: SCR brings together experts in medicine, clinical research, nursing, pharmacy, laboratory science, data and quality management, all experienced in early-stage drug development.
• Enjoy meaningful benefits: As a not-for-profit organisation, we offer salary packaging entitlements that can significantly increase your take-home pay.

Be part of a powerful research precinct: Co-located with Prince of Wales Hospital, Royal Hospital for Women, UNSW Sydney, and the Lowy Cancer Research Centre, SCR is uniquely positioned to drive real change in clinical research.

Primary Objective of Position:

Support the Quality Department's oversight of clinical study management to ensure compliance with Scientia Clinical Research (SCR) policy and procedures, protocols and applicable regulatory requirements.

Key Responsibilities:

• Assist in assuring that clinical studies meet internal and regulatory requirements, including GCP and GMP requirements as appropriate.
• Assist in following up staff with investigation, and CAPA completion related to deviations, quality events and audit findings
• Assist in the management of SCR's Quality Documents (e.g. SOPs, etc.) within SCRselectronic qualitymanagementsystem (eQMS)
• Assist in hosting sponsor/CRO audits and inspections
• Assist with the completion and management of the internal audit program
• Assisting in managing SiteDocs (electronic Investigator Site File).
• Assist in developing and delivering quality assurance training programs.
• Contribute to relevant Quality Document (e.g. SOPs, etc.) review and revision as required

Behavioural Skills

• Excellent technical and clinical writing skills
• High attention to details and a passion for consistency, standards, accurate and complete documentation
• Ability to drive projects in a proactive and independent manner
• Excellent organizational and interpersonal skills; including the ability to competently liaise and provide feedback to internal and external collaborators regarding project issues.
• Ability to work independently as well as within a cross functional team

Technical and Skills

• A science degree in life science or similar areas
• Knowledge of GCP desirable
• Experience with quality assurance activities desirable

Seniority level

• Seniority levelEntry level

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance
• IndustriesResearch Services

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