Clinical Research Specialist

6 days ago

Sydney, New South Wales, Australia beBeeGastroenterologist Full time $176,296 - $193,784

Seeking an experienced gastroenterologist to lead a clinical trial team as a sub-investigator or independent clinician. The successful candidate will contribute medical expertise and ensure the highest standards of patient safety, scientific integrity, and regulatory compliance.

This is a unique opportunity to take on a pivotal role in a first-in-human study involving a monoclonal antibody. The chosen candidate will be responsible for overseeing study-specific procedures, including endoscopies, and supporting the principal investigator in all aspects of trial conduct.

The ideal candidate will possess specialist registration in gastroenterology and clinical experience managing patients with inflammatory bowel disease. A strong understanding of ICH-GCP guidelines and clinical research best practices is essential. Excellent communication and interpersonal skills are also required to collaborate effectively with multidisciplinary teams.

Key Responsibilities:

  • Conduct and 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
  • Monitor patient safety, manage adverse event reporting, and ensure prompt escalation of safety concerns
  • Collaborate with research teams 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 and monitoring visits as required
  • Provide medical expertise to discussions with ethics committees, sponsors, and regulators where applicable

Requirements:

  • 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
  • Availability to attend study visits and perform endoscopies (as required) at the clinical trial sites

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