Clinical Trials and Regulatory Specialist
Salary Level: Classification Level 7 (Salary range A$84,974 to A$92,890 per annum plus up to 17% employer superannuation contributions).
Appointment: Full-time, fixed-term (3 years 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, USC Clinical Trials Centre, the Clinical Trials and Regulatory Specialist supports the implementation and conduct of clinical research in accordance with the appropriate quality standards including ICH/GCP, USC CTC SOPs, and applicable regulations, rules and guidance. A key focus of this role will be to coordinate the ethics, governance and contractual aspects of all clinical trials within the USC Clinical Trials Centre network. It is expected that the person in this role will work efficiently to prepare and coordinate all documentation required to gain Human Research Ethics Committee (HREC) approval and Governance approval during the duration of a project including initial approval and ongoing annual reports and amendments.
- Manage administrative, regulatory staff members involved in ethics, governance and external regulatory approval processes
- Responsible for managing the site approval process for clinical trials across the network over 18 site locations including USC Sunshine Coast, USC Health Hub Morayfield, USC Mackay.
- An authority on regulatory issues and able to apply strategic planning to a complex, geographically dispersed network of independent sites.
- Implement policies, procedures and performance measures which support a contemporary approach to clinical trial approval.
- Responsible for managing the clinical trial management software platform (CTMS) and trial feasibility platform (Devana).
- Undertake consultation, liaison and negotiation with Principal Investigators and Research staff in the USC Clinical Trials Centre network on the preparation of ethics and governance applications and contracts for research projects
- Participate in the preparation of initial ethics submission package application, working closely with the Lead Clinical Trial Coordinator to ensure necessary milestones are completed as required.
- Work closely with the applicable external Human Research Ethics Committee (HREC) and the USC Human Research Ethics Office to ensure requirements for submission and ongoing annual reporting are met.
- Coordinate start up document management, including collating all essential documents required to be included in the Investigator Site Files.
- Monitor projects for ethics/governance compliance by ensuring ongoing annual reporting and protocol amendment requirements are met.
- Be the primary point of contact for issues relating to Ethics and Governance submissions, status and feedback.
- Assist the Director with preparation and negotiation of budgets and contracts for research projects.
- Highly developed communication and interpersonal skills, including proven achievement in effectively liaising and consulting with key stakeholders.
- Manage competing demands of multiple projects, simultaneously.
- Adhere to all aspects of confidentiality in relation to clinical data.
- Support the orientation and training of new research team members and other staff.
- Contribute to the planning, management and effective implementation of continuous improvement activities relating to relevant practices, protocols, quality assurance standards and customer service excellence
The successful candidate will hold a tertiary qualification in Health Science/Bio-Medicine or similar education/training and experience and demonstrate the following knowledge and skills:
- Demonstrated experience, expertise and broad knowledge in ethics/regulatory affairs frameworks.
- Detailed knowledge of clinical research practices, including an understanding of the contractual and ethical obligations of clinical trials, development and monitoring of trial budgets, and ICH Good Clinical Practice.
- High level computing skills (including databases, clinical trial electronic data entry, word processing and spreadsheets).
- Sound understanding of privacy principals governing health information.
- Ability to work independently and as part of a multidisciplinary team.
Additionally, in accordance with the University’s Staff Code of Conduct – Governing Policy, all staff are expected to display professional behaviour, communicate respectfully, and perform their duties responsibly. A role statement is not intended to limit the scope of a role but to highlight the key aspects of the role. The requirements of the role may be altered to meet the changing operational needs of the University.
Contact for Further Information
Clinical Trials Operations Manager
Clinical Trials Centre
07 5456 3798
Midnight, Monday 12 November 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.