Innomed is a clinical-stage biotechnology company focused on developing first-in-class and best-in-class cardiovascular and metabolic therapies, leveraging proprietary drug delivery and translational platforms. The company is preparing for an HK IPO, with active multi-regional clinical trials in China, the US, Canada, and Australia.
About the Role
Candidates based in Melbourne are preferred.
Responsibilities
- Address study-related clinical site issues, initiate and communicate corrective action as indicated, and ensure all follow-up is properly documented to protect patient safety, welfare, and rights
- Support project organization, management, and execution; identify non-adherence and ensure trials are conducted, recorded, and reported in accordance with the protocol, regulations, GCP, ICH Guidelines, SOPs, Monitoring Plans, and quality standards
- Participate in study startup, site opening, study conduct, and site closure
- Manage clinical investigative site activities across multiple protocols and therapeutic areas
- Ensure integrity and quality of site data and timely reporting/follow-up of all safety events
- Conduct independent monitoring visits (at least 1 year of clinical research monitoring experience required); support/conduct on-site and remote monitoring visits (qualification, initiation, interim, closeout) for Phase 1–4 studies
- Train site personnel on protocols and regulatory requirements in collaboration with project teams; elevate serious or outstanding issues
- Facilitate Quality Assurance audits and ensure regulatory inspection readiness at assigned sites
- Prepare and submit accurate monitoring and administrative reports
- Support Clinical Trial Application submissions, including informed consent updates and translations
- Assist with study budget preparation and clinical trial agreement execution; negotiate investigator/hospital agreements
- Support continuous improvement initiatives within Clinical Operations
- Promote a \"White Glove Service\" culture in stakeholder engagement, including investigative sites
Qualifications
- Bachelor's degree in life sciences, healthcare, or equivalent work experience
- Preferred: 1+ year CRA experience in a medical, pharmaceutical, or CRO setting; Phase 3 double-blinded experience; industry-sponsored clinical research knowledge; understanding of ICH/GCP Guidelines and applicable regulations
- Strong planning, organizational, analytical, and communication skills
- Ability to work effectively in a fast-paced environment with competing priorities
- Demonstrated business ethics, integrity, and sound judgment
Required Skills
Not specified.
Preferred Skills
- Cardiovascular and oncology clinical trial experience
Pay range and compensation package
AUD100,000–120,000 annually.
Equal Opportunity Statement
We are committed to diversity and inclusivity in our hiring practices.
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