Quality and Training Specialist
Salary Level: Classification Level 7 (Salary range A$84,974 to A$92,890 gross per annum plus up to 17% employer superannuation contributions)
Appointment: Full-time, fixed-term (2 year duration)
USC will be a university of international standing, a driver of capacity building in the Sunshine Coast and broader region, and an unsurpassed community asset.
University Strategic Goals
The University will be:
- A comprehensive university of 20,000 students by 2020;
- Positioned in the global tertiary education community as a top-100 university under 50 years of age; and
- A primary engine of capacity building in the broader Sunshine Coast region, from Brisbane to the Fraser Coast.
Overview of Clinical Trials Centre
USC has established a world class Clinical Trials Centre which builds the region’s collective clinical research capacity and delivers innovative and regionally relevant research in consultation with key stakeholders, including local healthcare professionals, pharmaceutical executives, and other key thought leaders.
Overview of the Role
Under the broad direction of the Director, the Quality and Training Specialist (QTS) ensures planning, coordination, control and continuous improvement of processes and methods is 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.
Key Accountabilities (include but not limited to):
- Provide leadership and direction to the USC CTC project teams and Investigators across the site network to ensure quality assurance compliance with all internal procedures, internal University quality standards, ICH GCP and applicable regulatory guidelines.
- Utilising a risk-based approach, develop, implement and maintain ICH GCP compliant policies, procedures and performance measures which control the quality of work conducted at USC CTC and support a contemporary approach to clinical trial conduct.
- An authority on quality systems, processes and frameworks. Able to apply strategic planning and design to a complex, geographically dispersed network of independent sites.
- Work to ensure the USC CTC Quality Management System is implemented and is highly regarded by our international industry partners.
- Perform routine and non-routine quality assurance audits to include: Investigator sites, vendors, processes, systems, study project and document reviews.
- Responsible for the training and credentialing of new staff.
- Coordinate the review and approval process of contracts and agreements
- Assist in the hosting of regulatory audits as necessary.
- Write and review clinical SOPs and other quality documents.
- Develop and implement detailed audit plans and schedules.
- Ensure timely and effective follow up of all identified or assigned quality issues.
- Ensure all applicable contracts and agreements are in place for USC CTC consultants and service providers.
- Assist in preparing USC CTC investigational sites for regulatory inspections as necessary.
- Lead the development and delivery of internal training programs and competency assessments.
- Keep up-to-date with relevant guidelines and assist with regularly scheduled internal training.
- Write and review procedures and other controlled documents.
The successful candidate will hold a tertiary qualification in Health Science/Bio-Medicine or similar education/training and experience.
Applicants must demonstrate the following knowledge and skills:
- 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.
- Excellent interpersonal, verbal and written communication, with sound negotiating and conflict resolution skills.
- Strong problem solving, risk assessment and impact analysis abilities.
- High level computing skills.
- Excellent time management skills and a genuine commitment to accuracy and exceptional attention to detail.
- Demonstrated ability to communicate effectively with all levels of staff and stakeholders, to form and maintain effective working relationships within the organisation and with external bodies.
- Demonstrated ability to prioritise effectively, manage multiple tasks, meet deadlines and achieve required outcomes.
- Sound understanding of privacy principals governing health information.
- Ability to work independently and as part of a multidisciplinary team.
- Ability to be flexible to travel to differing site locations.
Contact for Further Information
Clinical Trials Operations Manager
Clinical Trials Centre
07 5456 3798
Midnight, Thursday 26 July 2018
All applicants MUST provide both a statement of claims and resume/curriculum vitae.
Information regarding how to prepare your application and write an effective statement of claims is available on our website information for applicants
As part of your role, you may be required to travel to any one of USC's locations.
To apply please click the Apply button at top of screen.
USC values diversity, enables access and promotes inclusion.
USC strongly encourages applications from Aboriginal and Torres Strait Islander people.