Clinical Research Quality Assurance Lead

1 week ago

Sydney, New South Wales, Australia beBeeLeadership Full time $109,857 - $129,624
Job Title:

Quality Assurance Specialist

Job Description:

We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team. The successful candidate will be responsible for leading the quality, regulatory compliance, and ICH-GCP adherence of clinical trial monitoring and site operations.

The ideal candidate will have relevant tertiary qualifications in life sciences, allied health, or clinical research, with post-graduate training or equivalent experience in clinical trials, research coordination, or biostatistics. They will also have minimum 3–5 years' experience in clinical research, including demonstrated ability to work independently and collaboratively, and contribute to quality improvement initiatives.

Key Responsibilities:
  • Oversee site readiness for audits and inspections, including risk assessments and implementation of mitigation strategies.
  • Manage all aspects of site research activities, including trial timelines, data quality, investigational product handling, and staff training.
  • Drive operational excellence by developing policies, reviewing incidents, supporting accreditation, and advising on study budgets and processes.
  • Provide strategic leadership in clinical research planning and execution, ensuring high standards of governance, compliance, and continuous improvement.
Required Skills and Qualifications:
  • Relevant tertiary qualifications in life sciences, allied health, or clinical research, with post-graduate training or equivalent experience in clinical trials, research coordination, or biostatistics.
  • Minimum 3–5 years' experience in clinical research, including demonstrated ability to work independently and collaboratively, and contribute to quality improvement initiatives.
  • Strong leadership, negotiation, and interpersonal skills with the ability to communicate effectively, motivate teams, and manage complex stakeholder relationships.
  • Proven ability to deliver accurate, timely reporting and apply robust analytical and financial management skills within a clinical trial or research setting.
Benefits:
  • Discounted access to many gyms for you and your family with Fitness Passport.
  • Access to discounted private health insurance with Medibank.
  • Make a proportion of your salary tax-free.
About Us:

We are a reputable healthcare organization committed to providing high-quality care to our patients. Our team is passionate about delivering exceptional service and making a positive impact in our community.

Our organization is dedicated to fostering a culture of inclusivity, respect, and empathy. We celebrate diversity and promote equal employment opportunities for everyone.

  • Clinical Researcher

    1 week ago

    Sydney, New South Wales, Australia Paratus Clinical Research Full time

    Are you interested in clinical research?Ever wondered how evidence is gathered in clinical practice?At Paratus Clinical, we are focused on delivering high quality clinical trials, leading the way in the execution of primary care trials in Australia.Paratus Clinical was proud to have been involved in the early COVID vaccine trials at the height of the...

  • Senior Research and Quality Assurance Specialist

    7 days ago

    Sydney, New South Wales, Australia beBeeFellowship Full time $90,000 - $120,000

    Postgraduate Fellow OpportunityThis role presents a unique chance to work in Research and Quality Assurance within an Intensive Care Unit. As a Postgraduate Fellow, you will operate at a consultant level, with senior support available at all times.The role encompasses 50% clinical duties and 50% non-clinical time in the ICU Research and Clinical Governance...

  • Clinical Research Associate II/ Senior Clinical Research Associate

    2 weeks ago

    Sydney, New South Wales, Australia Pharmaceutical Research Associates, Inc Full time $90,000 - $120,000 per year

    Overview Title: Clinical Research Associate II/ Senior Clinical Research Associate Location: Melbourne, Sydney (home-based) As an experienced Clinical Research Associate, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be part of an innovative and global Biotechnology...

  • Clinical Trial Assistant

    2 weeks ago

    Sydney, New South Wales, Australia Canopy Clinical Research Full time

    OverviewDirect message the job poster from Canopy Clinical ResearchClosing patient access gaps in clinical research.We have an exciting opportunity to join a collaborative team of Clinical Research professionals focused on improving patient outcomes through Phase I to IV clinical trials in our Sutherland Shire site.We are seeking a dynamic Clinical Trials...

  • Clinical Trial Assistant

    2 weeks ago

    Sydney, New South Wales, Australia Canopy Clinical Research Full time

    OverviewDirect message the job poster from Canopy Clinical ResearchClosing patient access gaps in clinical research. We have an exciting opportunity to join a collaborative team of Clinical Research professionals focused on improving patient outcomes through Phase I to IV clinical trials in our Sutherland Shire site.We are seeking a dynamic Clinical Trials...

  • Clinical Trial Assistant

    2 weeks ago

    Sydney, New South Wales, Australia Canopy Clinical Research Full time

    OverviewDirect message the job poster from Canopy Clinical ResearchClosing patient access gaps in clinical research. We have an exciting opportunity to join a collaborative team of Clinical Research professionals focused on improving patient outcomes through Phase I to IV clinical trials in our Sutherland Shire site.We are seeking a dynamic Clinical Trials...

  • Clinical Research Associate Ii

    1 week ago

    Sydney, New South Wales, Australia Emerald Clinical Full time

    OverviewJoin to apply for theClinical Research Associate IIrole atEmerald Clinical.AtEmerald Clinical, we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical,...

  • Clinical Research Associate II

    2 weeks ago

    Sydney, New South Wales, Australia Emerald Clinical Full time

    OverviewJoin to apply for the Clinical Research Associate II role at Emerald Clinical.At Emerald Clinical, we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical,...

  • Clinical Research Associate II

    2 weeks ago

    Sydney, New South Wales, Australia Emerald Clinical Full time

    Overview Join to apply for the Clinical Research Associate II role at Emerald Clinical. At Emerald Clinical, we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting...

  • Clinical Research Associate II/ Senior Clinical Research Associate

    2 weeks ago

    Sydney, New South Wales, Australia Pharmaceutical Research Associates, Inc Full time $90,000 - $120,000 per year

    Overview Title: Clinical Reseasrch Associate II/ Senior Clinical Reseasrch Associate Location: Melbourne, Sydney (home-based) As an experienced Clinical Research Associate, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be part of an innovative and global...