Sub Investigator

Vor 6 Tagen


Council of the City of Sydney, Österreich Vial Vollzeit

Who We Are Vial Australia Pvt Ltd is the Australian arm of Vial, a cutting‑edge clinical research organization dedicated to advancing innovative therapeutics through efficient clinical trials. Vial Australia leverages local expertise and infrastructure to conduct high‑quality clinical trials for Vial's extensive drug portfolio. About the Job Our mission is to bring transformative medicines to patients by executing world‑class clinical research in Australia. We combine Vial's innovative approach to clinical trials with Australia's robust regulatory framework and experienced clinical research community. Vial Australia Pvt Ltd operates as a key strategic partner in Vial's global clinical development programs, providing access to Australia's diverse patient populations and streamlined regulatory pathways. We are committed to maintaining the highest standards of clinical research while accelerating the development of life‑changing therapies. What You'll Do We are seeking a Medical Officer to join our clinical trial team as a contractor Sub‑Investigator / Independent Clinician (in a supporting capacity to the Principal Investigator). This is a unique opportunity to contribute clinical expertise to a First‑in‑Human (FIH) study involving a monoclonal antibody for IBD, playing a pivotal role in ensuring patient safety, scientific integrity, and adherence to regulatory standards. Key Responsibilities Perform and/or oversee study‑specific procedures, including endoscopies at protocol‑defined timepoints Support the Principal Investigator in all aspects of trial conduct, including protocol adherence, patient safety oversight, and data integrity Assess and monitor patient safety, manage adverse event reporting, and ensure prompt escalation of safety concerns Collaborate with the research team, study coordinators, and site staff to ensure smooth execution of study visits Review and sign off on source documentation, case report forms, and other trial‑related documents in compliance with ICH‑GCP standards Participate in investigator meetings, monitoring visits and more as required Contribute medical expertise to discussions with ethics committees, sponsors, and regulators where applicable What You'll Bring Medical registration with AHPRA (specialist registration in Gastroenterology or a relevant specialty preferred but not essential) Clinical experience managing patients with IBD (essential) Previous involvement in clinical trials preferred but not essential; training will be provided Familiarity with ICH‑GCP guidelines and clinical research best practices Strong attention to detail and commitment to high‑quality clinical research Excellent interpersonal and communication skills, with the ability to collaborate effectively with multidisciplinary teams Availability to attend study visits and perform endoscopies (as required) at the clinical trial sites Why You'll Love Working at Vial Australia Innate curiosity. At our core, we embody an insatiable curiosity. Our journey into the realm of clinical trials was ignited by a first‑hand understanding of the challenges involved. This drives us to constantly innovate, seek fresh ideas, and bring our vision of reimagining clinical trials to life. Fostering autonomy. Autonomy is our guiding principle. We believe that when team members are entrusted with responsibility, they unleash their true potential. Our culture empowers people to take ownership and make a real impact. Seniority level Not Applicable Employment type Part‑time Job function Other, Information Technology, and Management #J-18808-Ljbffr



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