07 Nov
|
Inno Medicine
|
Melbourne
07 Nov
Inno Medicine
Melbourne
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 in office 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 annually.
Equal Opportunity Statement
We are committed to diversity and inclusivity in our hiring practices.
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📌 Cra (Melbourne)
🏢 Inno Medicine
📍 Melbourne