Study Start-Up Specialists

General role description

Study Start-Up Specialists support the early phases of clinical trials by coordinating the documents, approvals, and systems needed to activate trial sites. They liaise with internal teams and site staff to ensure ethics, regulatory, and governance requirements are met before participant recruitment can begin. Their work plays a crucial role in launching studies on time and in compliance with national and international standards.

Key tasks and responsibilities

  • Coordinate the collection, review, and tracking of essential site documents, such as investigator CVs, training records, and regulatory forms
  • Assist with ethics and regulatory submissions, including Human Research Ethics Committees (HRECs), the Therapeutic Goods Administration (TGA), and research governance offices
  • Support site feasibility assessments and help evaluate site readiness for participation in clinical trials
  • Act as a primary contact for site staff during the start-up phase to support document collection, submissions, and approvals
  • Help prepare and adapt patient-facing documents, such as informed consent forms, to meet local ethics and regulatory requirements
  • Maintain up-to-date tracking tools and clinical trial systems to monitor start-up progress and timelines
  • Collaborate with clinical project managers, contract teams, and regulatory staff to align start-up activities and meet project goals

Workplace settings

  • Contract Research Organisations (CROs)
  • Pharmaceutical, biotechnology and medical device companies

Required qualifications

  • A degree in life sciences, health sciences, biomedical science, or a related field

Other notable requirements

This role typically requires:

  • Familiarity with Australian ethics and governance requirements for clinical trials
  • Understanding of Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines
  • Strong attention to detail and ability to manage multiple tasks to meet deadlines
  • Effective written and verbal communication skills
  • Experience with clinical trial tracking systems and document management tools
  • Prior experience in clinical research start-up, coordination, or regulatory support is often preferred

Common entry points

Regulatory Affairs Administrator

Study Start-Up Associate

Common next roles

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