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Associate Good Clinical Practice Inspector

Background information on Section and Branch  
  
The Branch is responsible for undertaking post-market monitoring of medicines and vaccines to ensure that they continue to maintain an appropriate level of quality, safety and efficacy following entry into the Australian marketplace. Branch functions also include the pharmacovigilance and Good Clinical Practice (GCP) inspection program, and the evaluation and monitoring of Risk Management Plans for high-risk medicines. 
      
Duties of position   
  
Specific duties include:

  • Participating in inspections of sites involved in the clinical trial of unapproved therapeutic goods in Australia,
  • Assessing evidence to determine compliance with applicable GCP regulatory requirements
  • Preparing inspection reports and making recommendations on inspection outcomes
  • Liaising, engaging, and collaborating with both internal and external stakeholders, to resolve complex and/or sensitive issues in relation to compliance with legislation, regulations, and standards
  • Applying technical knowledge and providing advice to colleagues to guide project and program activities
  • Making robust regulatory decisions and recommendations based on critical evaluation and sound judgement
  • Contributing to team goals and broader organisation objectives by undertaking other tasks as required
  • Working effectively as a team member, displaying flexibility and innovation in overcoming obstacles  

Start date
ASAP
  
End date   
30 September 2022
  
Possibility of extension    
Yes
  
Location   
Canberra or Sydney
  
Domestic travel required for the role     
This position may require interstate travel, for up to 3-4 days at a time, to inspect clinical trial sites.

Selection Criteria
  
Mandatory requirements
  
Candidates must be able to demonstrate:
  
A degree in science or equivalent qualification relevant to clinical research
  
Desirable  

  • Recent practical experience in monitoring academic or industry-sponsored clinical trials
  • Experiencing conducting audits or similar compliance role
  • Regulatory and/or clinical trial industry experience
  • Understanding of the regulation of clinical trials in Australia

If interested, please apply directly through the links provided. Alternately, contact Kalpana Palaniyappa for more information.
  
Kalpana Palaniyappa
0403 200 666  
kalpana.palaniyappa@calleo.com.au 

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