Quality and Training Specialist
The USC Clinical Trials Centre requires a specialist to ensure quality and compliance of clinical trials studies.
Summary about this job
Clinical/Medical Research
Company: University of the Sunshine Coast
Location: Sunshine Coast
Work type: Full Time
Salary: n\a
Phone: +61-7-6642-1917
Fax: +61-3-8732-2323
E-mail: n\a
Site: n\a
Detail information about job Quality and Training Specialist. Terms and conditions vacancy
Sunshine Coast
- Full-time, fixed-term position, 2 years duration
- Salary: Classification Level 7 (Salary range A$84,974 to A$92,890)
- Based at the beautiful Sunshine Coast with travel to other site locations
Clinical Trials Centre
The University of the Sunshine Coast (USC) has established a world class Clinical Trials Centre (CTC), which through partnerships with medical experts and industry is bringing advanced treatments and breakthrough therapies to our communities. The Clinical Trials Centre is now seeking a Quality and Training Specialist to join their expanding team to ensure consistency, cohesion, adherence and compliance of clinical studies across all sites.
Overview
The Quality and Training Specialist ensures processes and methods are established to control the quality of studies conducted within the USC Clinical Trials Centre site network. The position will be responsible for assessing compliance with USC CTC standard operating procedures (SOPs), ICH GCP guidelines, national and local research regulations and guidelines and clinical study protocols. This position will take a lead role in the development, implementation and maintenance of the USC CTC Quality Management system and training program.
Responsibilities
- Some of the key responsibilities include:
- Develop, implement and maintain ICH GCP compliant policies, procedures and performance measures.
- Apply strategic planning and design to a complex, geographically dispersed network of independent sites.
- Training and credentialing of new staff.
- Coordinate contracts and agreements.
- Develop and implement clinical SOPs, detailed audit plans and schedules.
- Perform quality assurance audits and assist in hosting regulatory audits and inspections.
Requirements
To be considered for this role, you must have the following:
- A tertiary qualification in Health Science/Bio-Medicine or similar education/training and experience.
- Previous experience in developing and working on compliance and regulatory affairs in a clinical research environment or similar.
- Thorough knowledge of clinical trial requirements during their life-cycle from start up to close out including a detailed understanding of the regulatory and ethical approval process across Australia.
- Previous experience in developing/implementing audit plans and procedures and ICH GCP audit/training experience.
Apply
All applicants must provide both a statement of claims and resume/curriculum vitae. Obtain the role statement and information regarding how to prepare and submit your application from our website, http://www.usc.edu.au/connect/work-at-usc.
You must have a current right to work in Australia to apply for this job.
Applications close: Midnight Thursday 26 July 2018
More information:
Georgina Street
Clinical Trials Operations Manager
Clinical Trials Centre
07 5456 3798
[email protected]