Clinical Operations Associate

RAGE Biotech is an early-stage Australian biotech company advancing a novel inhaled antisense oligonucleotide therapeutic for the treatment of chronic respiratory disease. Our lead program is preparing to enter a first-in-human (FIH) clinical study in Australia. We operate with a lean, highly collaborative team and partner closely with CROs, vendors, and external experts.

Position Summary

We are seeking a proactive and adaptable Clinical Operations Associate to join our team and provide critical support across clinical study operations. This role offers the opportunity to gain broad exposure to early-phase clinical development, with involvement in study start-up, vendor management, regulatory documentation, and study tracking. The position is ideal for someone looking to deepen their operational experience in a flexible, science-driven environment.

Key Responsibilities

Core responsibilities - supporting the FIH study:

• Support sponsor responsibilities for regulatory submissions (e.g. CTN, clinical trial registry entry) and maintain relevant documentation
• Coordinate with site staff for ethics submission timelines, PICF review, and other investigator-led materials
• Track CRO-led project activities and deliverables, escalating delays or risks to the sponsor study team
• Review meeting agendas, minutes, and action logs prepared by the CRO and ensure timely follow-up
• Maintain study trackers and dashboards, including timelines, milestone status, and site readiness indicators
• Support TMF/eTMF oversight through spot checks, QC of essential documents, and reconciliation activities
• Assist with preparation of internal sponsor meetings, including document collation, calendar coordination, and tracking decisions/actions Liaise with vendors (e.g. central lab, bioanalytical, data management) to support alignment and communication
• Assist with safety documentation review workflows (e.g. SUSAR distribution logs, safety letter tracking) in collaboration with CRO/pharmacovigilance provider
• Support reconciliation of data across key systems (e.g. IVRS, eCRF, lab reports) under direction of the sponsor or CRO
• Track vendor invoices and assist with budget tracking and reconciliation
• Contribute to the development and maintenance of sponsor-controlled documents, logs, trackers, and QMS documentation (e.g. SOPs, filing conventions)
• Assist with vendor identification and RFI coordination for future studies (e.g. CROs, central labs, EDC providers)
• Support country feasibility assessments and site identification activities
• Contribute to clinical operations input on protocol drafts, informed consent forms, and study plans
• Assist with budget model development and forecasting for future Phase 2 studies
• Help prepare cross-functional operational plans, including timelines, risk logs, and resource needs
• Participate in lessons learned activities and process improvement initiatives from the FIH study

Qualifications and Experience

• Bachelor's degree in life sciences, pharmacy, public health, or a related discipline
• Understanding of ICH GCP principles and Australia's clinical trial landscape (CTN process, HREC)
• ICH GCP certification (current or to be obtained before study start)
• Strong written and verbal communication skills
• High attention to detail and strong organisational skills
• Ability to work independently and take initiative in a dynamic, fast-paced setting
• Previous experience in a clinical trial coordinator, CRA, or clinical project support role
• Experience working with CROs and vendors
• Familiarity with TMF systems and clinical trial project management tools (e.g., ClickUp)

Our Ideal Candidate

You are curious, solution-oriented, and eager to learn. You're comfortable wearing multiple hats, stepping into ambiguity, and contributing to the success of a small team. You thrive in an environment that values integrity, scientific rigour, and flexibility.

What We Offer

• Opportunity to contribute to a FIH clinical study in a growing Australian biotech
• Exposure to end-to-end clinical development activities
• Hybrid working model with flexible hours
• Supportive and collaborative team culture
• Potential for role evolution as the program advances
• Salary Range: AUD $100,000 – $120,000 plus superannuation

Seniority level

• Seniority levelEntry level

Employment type

• Employment typeFull-time

Job function

• Job functionResearch, Analyst, and Information Technology

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