Ethics Submission Report Officer - Clinical trials

This is a remote position.

Work remotely | Full-time | Support clinical trials across Australia

We are seeking a highly organised and detail-oriented Ethics Submission Support Officer to join a growing offshore team. This role plays a critical part in supporting the preparation and coordination of ethics and governance submissions for clinical trials.

You’ll work closely with our Australia-based Ethics & Governance team, sponsors, and research sites to ensure submissions are delivered accurately and on time.

In this role, you'll be required to:

• Efficiently prepare and co-ordinate all documentation required to gain Human Research Ethics Committee (HREC) and Research Governance Office (RGO) approval for the clinical trials under the role’s administration to a high standard and in accordance with stakeholder and institutional key performance indicators.
• Be the primary point of contact for issues relating to ethics and governance submissions, as well as the status and any feedback related to the clinical trials under the role’s administration.
• Accurately and punctually record all ethics submission activities associated with the clinical trials under the role’s administration, including associated timelines and trial statuses within relevant databases, and other tracking software/spreadsheets; and
• Provide assistance to, and ad hoc cover for, other team-mates, as and when required, to ensure that agreed service delivery levels are met.

Key Responsibilities

• Assist and prepare required Ethics and/or Governance submissions, as per Ethics Committee / Sub-Committee / Directorate requirements (e.g., preparation of the main ethics application form, modification of the Participant Informed Consent Forms, Site Specific Forms, etc.,).
• Notify, and co-ordinate the sign-off of governance submission components by site (e.g., site supporting health service departments such as pharmacy and pathology).
• Coordinate signatures from Site (PIs, Head of Departments).
• Co-ordinate feedback, e.g., in response to queries, to / from HREC / RGO with the Sponsor / PI.
• Co-ordinate document exchange for single and multi-site submissions.
• Identify and proactively address potential delays to clinical trial submissions.
• Submit accurate invoice requests for HREC/RGO fees.
• Update status of clinical trial activity in the Clinical Trial Management System (CTMS) and other relevant tracking spreadsheets/software.

• Present a professional and positive image at member site and with sponsors / CROs
• Follow up and action sponsor queries in a timely manner.
• Update site and sponsor regarding relevant processes and HREC requirements.
• Advise Team Leader – Ethics and Governance regarding relevant site processes.
• Advise Sponsor regarding study approval processes at site, HREC requirements and related timelines.
• Exchange relevant documentation with sponsor to process submissions.
• Facilitate regular communication between sponsor and HREC / RGO.

• Preparation of documents related to each study for the Ethics Team / Site, as delegated.
• Uploading of documents to organisaton's and / or the member site’s shared folder system (E.g., clinical trial management system)
• Completion of general administrative tasks, as required.

Requirements

Qualifications:

The minimum educational, technical, or professional qualifications required to competently perform this role include:

• Tertiary qualification in Health, Life Sciences or other related qualifications, with sound knowledge of medical terminology/ scientific language.

Experience:

• At least 12 months’ experience in / exposure to working on ethics / governance processes in a medical administration or clinical research environment.
• Strong organisational and time management skills with the ability to work with a complex set of tasks; to plan and prioritise workload to meet deadlines and work independently, efficiently, and effectively
• Excellent communication and influencing skills with a demonstrated ability to communicate with a wide range of people, including researchers and other external stakeholders.
• Demonstrated experience in the coordination and/or review of Human research ethics applications (preferred)

Skills and Knowledge:

• Ability to develop and maintain professional relationships with team members and external stakeholders.
• Project Coordination in alignment with agreed timelines.
• High level of attention to detail.
• Competent computer literacy skills, including the proficient use of Microsoft Office applications such as Word, Excel, Outlook and Teams.
• Ability to communicate professionally, orally and written.
• High level of organisational skills and time management.

Benefits

Be part of a purpose-driven organisation advancing cancer research

Work with leading clinical trial professionals across Australia

Fully remote offshore role with a collaborative team culture

Opportunity to grow your career in clinical research and ethics governance