Senior Freelance Medical Monitor/Consultant

The Medical Monitor will serve as the primary clinical point of contact for investigative sites across Australia. Unlike global strategic MD roles, this position is operationally intensive and site-facing. The focus is on accelerating patient recruitment through real-time eligibility consultation, ensuring rigorous patient safety oversight, and providing immediate medical guidance to Principal Investigators (PIs) and Study Coordinators.

• Real-Time Site Engagement & Enrollment
  • Eligibility Gatekeeping: Review screening documentation and metabolic/endocrine labs in real-time to confirm patient eligibility, ensuring high-quality enrollment.
  • Site Q&A: Act as the “on-call” medical expert for sites to answer clinical questions regarding protocol inclusion/exclusion criteria.
  • Recruitment Acceleration: Partner with Clinical Research Associates (CRAs) to identify enrollment bottlenecks at the site level and provide medical solutions to overcome them.
• Patient Safety & Medical Oversight
  • Safety Monitoring: Conduct ongoing review of Adverse Events (AEs) and Serious Adverse Events (SAEs) for Australian sites, ensuring prompt reporting and patient protection.
  • Medical Integrity: Provide immediate medical assessment for protocol deviations to determine if a patient can safely continue in the trial and remind site that protocol deviations are not allowed.
  • Laboratory Review: Monitor laboratory values, including ECG, to identify early safety signals or trends.
• Site Relationship Management
  • Scientific Peer-to-Peer: In conjunction with the Sironax local manager, engage with Australian PIs to build rapport, ensuring the study remains a priority at the site level. (note: at the end of the study Sironax needs to have the rapport to go forward, not a consultant.)
  • SIV Participation: Lead medical portions of Site Initiation Visits (SIVs) to ensure site staff deeply understand the clinical nuances of the metabolic protocol and respond to any questions or misunderstandings of the protocol.

• Medical Degree (MD/MBChB)
• Current, unrestricted registration with the Australian Health Practitioner Regulation Agency (AHPRA) / Medical Board of Australia is required.
• Therapeutic Expertise: Minimum 5 years of clinical or industry experience in Internal Medicine with training in at least one of the following specialties: diabetes, endocrinology, metabolic diseases, obesity. Familiarity with GLP-1s or similar metabolic pathways is highly preferred.
• Local Landscape: Deep understanding of the Australian clinical trial ecosystem (TGA regulations, NHMRC guidelines).
• Soft Skills: High responsiveness and “service-oriented” mindset. The ability to translate complex medical protocols into actionable advice for site coordinators.

• Full legal working rights in Australia are required.

• This is a remote, part-time role requiring availability to respond to medical queries and safety-related issues within agreed timelines.
• Flexibility to participate in scheduled study team and safety review meetings is required.

This job description outlines the key responsibilities and requirements of the role and is not intended to be an exhaustive list of all duties. Responsibilities may be adjusted in line with study needs and organisational priorities.