Expert Gastrointestinal Specialist
5 days ago
We are seeking a Gastroenterologist to contribute clinical expertise to a First-in-Human (FIH) study involving a monoclonal antibody. The successful candidate will play a pivotal role in ensuring patient safety, scientific integrity, and adherence to regulatory standards.
As a Sub-Investigator / Independent Clinician, you will oversee study-specific procedures, including endoscopies at protocol-defined timepoints. You will also support the Principal Investigator in all aspects of trial conduct, including protocol adherence, patient safety oversight, and data integrity.
You will be responsible for assessing and monitoring patient safety, managing adverse event reporting, and ensuring prompt escalation of safety concerns. Additionally, you will collaborate with the research team, study coordinators, and site staff to ensure smooth execution of study visits.
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
- Specialist registration in Gastroenterology with AHPRA
- 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
We are looking for a dedicated and experienced Gastroenterologist who can contribute to the success of our clinical trial. If you have a passion for clinical research and a strong desire to make a difference, we encourage you to apply.
The ideal candidate will possess excellent communication and interpersonal skills, with the ability to work effectively in a team environment. They will also have a strong understanding of ICH-GCP guidelines and clinical research best practices.
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