Clinical Quality Associate

Hays Life Sciences

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$77,000 - $100,000
Work type
Full Time
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Full job description
  • Great environment to learn and develop
  • Impact on best practices
  • Excellent work- life- balance

Exciting GCP Quality Associate position with Australian CRO. Office- based in Melbourne. Close- knit team.

Your new company
Hays Life Sciences are partnering with a niche Australian CRO that are expanding in Australia to support them recruiting an experienced Clinical Quality Associate. With an experienced and talented clinical operations team present in Australia running local clinical trials this position will mainly support the clinical operations team and will report to the CEO of the organisation; the company are looking for a permanent Clinical Quality Associate, office- based in Melbourne.

Your new role
The Clinical Quality Associate will be responsible for:

  • Updating about changes to regulations/ guidelines relating to activities within GCP
  • Assisting staff in implementation of quality policy and identified regulations/ guidelines
  • Writing and updating local Quality Documents
  • Provide advice and support in quality assurance related matters to Clinical Operations staff
  • GCP related Training of Clinical Operations staff
  • Managing clinical operations specific CAPAs
  • Supporting internal and external audits and regulatory inspections
  • Defining and following quality risk prevention plans
  • Supporting the Clinical team with preparation, conduct and development of responses to health authority inspections of studies and operational activities
  • Conducting study and system related audits

What you'll need to succeed

  • Bachelor Degree in Health or Life Sciences and extensive experience within Clinical Research
  • Working experience coming from a Clinical Operations background in a pharmaceutical, biotechnology or contract research organisation
  • Experience in GCP Quality
  • Excellent communicator, who can work well with the local clinical operations team to guide and support them
  • Demonstrated ability in Project Management
  • Lateral thinker, who can use their expertise to solve problems
  • Excellent communication and interpersonal skills
  • Ability to work effectively in a team
  • Open to learning and taking on new responsibilities
  • Excellent organisation and time management skills

What you'll get in return

  • Work on cutting edge studies
  • No travel and great company culture working in a close- knit team of experienced professionals
  • Varied role
  • Flat structure
  • Company benefits like salary packaging, leave loading, additional days off
  • Excellent opportunity for an experienced clinical study oversight manager to move to a Quality role

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV to Krisztina Auth [email protected], or call me now on 03 9804 53133.
If this job isn't quite right for you but you are an experienced clinical research professional looking for a new position in the industry, please contact me for a confidential discussion on your career.

SA Licence number : LHS 297508

Job details
Date posted
6 Dec 2019
31 Dec 2019
Healthcare & Medical
Other (Healthcare & Medical)
$77,000 - $100,000
Contract type
Work type
Full Time
Job mode
Standard/Business Hours
Work Authorisation
Australian Citizen/Permanent Resident