Clinical Trial Administrative Officer Level 1

Position Summary

The Clinical Trial Administrative Officer (CTAO) Level 1 is responsible for providing administrative and clerical support and expertise to ensure effective and efficient team and clinical trial operations. In conjunction with team members, the CTAO will be responsible for maintaining appropriate regulatory documents and ensuring regulatory compliance in the conduct of clinical trials, in accordance with the International Conference for Harmonization (ICH) guidelines for good clinical practice (GCP), National legislation and the principles of the National Clinical Trials Governance Framework. This role will act as a main conjugate between clinical trial sponsors, assisting with monitoring processes and deliverables.

Enterprise Agreement

Health and Allied Services, Managers and Administrative Workers (Victorian Public Sector) (Single Interest Employers) Enterprise Agreement 2021-2025

Classification or Salary Range

Administrative Officer Grade 1 (HS1-HS17)

Immunisation Risk Category

Category B: Position unlikely to have contact with blood or other body fluid

Key Relationships

Education

Skills

Certifications, Licenses & Registrations

Key Accountabilities

1. Effective administrative support and expertise is provided to the clinical trials team members
• Provides administration support to the clinical trial staff for the day to day running of multiple clinical trials.
• Ensures all allocated trial related tasks are met in the designated timelines, in an organized manner and in accordance with ICH GCP.
• Understands the clinical trials regulatory environment and ensures regulatory compliance across the portfolio.
• Maintenance of regulatory files in accordance with ICH GCP and Unit’s SOP’s.
• Electronic and hard copy filing is conducted in a timely manner and in accordance to regulatory requirements.
• Effectively coordinates monitoring visits as required.
• Actively co-ordinate financial processes in compliance with institutional polices and regulatory guidelines. Develops and implements tools to oversee and facilitate patient reimbursement.

2. Database(s), clinical trial management system support is provided to team
• Provides support and acts as resource to unit staff in the use of the Clinibase clinical trial management system.
• Provides support to unit staff in the entry of data into relevant unit database(s).
• All requests for data entry are responded to and completed within allocated timelines.
• All data entered is accurate and verifiable against source data.
• Undertakes appropriate training where required allowing access to appropriate databases.

3. Teamwork
• Develops and participates in appropriate quality activities.
• Participates in unit and team meetings.
• Directly maintains a productive working relationship with staff within PCCTU and indirectly with Investigators, Clinical Research Organisations (CRO), and Clinical Research Associates (CRA) as well as trial sponsors.
• Well developed verbal and written communication skills.
• Ability to communicate to a wide range of individuals of various degree of seniority with confidence.
• Maintains confidentiality and displays discretion in dealing with fellow staff and patients.

4. High level organizational skills
• Demonstrates the ability to appropriately priorities competing tasks and workload.
• Works well under pressure and meets critical deadlines whilst maintaining consistent high standards.
• Demonstrates excellent organizational and forward planning skills.
• Demonstrates the ability to develop and maintain appropriate workload planning and tracking tools.
• Maintains high standards in quality clinical trial data entered.

5. Professional and personal development
• Takes an active role in unit discussions and will bring forward ideas and opinions.
• Where appropriate assists in the set up and orientation of new staff
• Attends relevant educational/professional forums.
• Participates in regular meeting within the unit e.g., team and unit meetings.
• Effective and timely communication with key stakeholders
• Acts in accordance with hospital policies
• Professional development is maintained and promoted
• Assists in the development of appropriate quality activities as per unit brief.
• Develop tools and strategies that improve team and unit efficiency.

Key Accountabilities (Contd..)