Job Title: Clinical Research Governance Specialist
We are seeking a highly skilled Clinical Research Governance Specialist to join our team. This role plays a crucial part in ensuring the regulatory integrity and compliance of clinical trials across our organisation.
The successful candidate will be responsible for:
* Maintaining and enhancing governance application processes in line with internal guidelines
* Reviewing and updating governance procedures, SOPs, and guidelines with Operations leadership
* Identifying and managing regulatory risk through accurate trial documentation
* Supporting training and education of staff on governance requirements
* Reporting on common submission queries, discrepancies, and errors
* Ensuring invoices are raised accurately following governance review
* Collaborating with internal teams to support timely study start-up
* Maintaining records, databases, and filing systems to ensure accuracy and efficiency
About You:
* You have minimum 3+ years' experience in clinical research, ideally with strong exposure to Research Governance and Ethics processes
* You possess knowledge of Medicines Australia, contracts, insurance, indemnity, and risk requirements
* You have strong organisational skills with high attention to detail and ability to manage competing priorities
* You have excellent written and verbal communication skills
* You are proficient with Microsoft Office and able to adapt to internal technology platforms
* You hold tertiary qualifications in Nursing, Medicine, Science, or related discipline
* You are an Australian Citizen or Permanent Resident