Senior Clinical Research Professional

4 days ago

Sydney, New South Wales, Australia beBeeClinicalResearch Full time $100,000 - $130,000
Job Title: Senior Clinical Research Associate

We are seeking a highly skilled and experienced Senior Clinical Research Associate to join our team.

Key Responsibilities:

  • Conduct on-site monitoring of clinical trials to ensure compliance with SOPs, regulations, and ICH guidelines.
  • Manage all aspects of the study at sites and provide timely updates to project managers.
  • Maintain accurate and compliant project documentation.
  • Assist in leadership roles or support project managers as needed.

Specific Duties:

  • Perform site qualification visits to discuss protocol requirements and trial staff training.
  • Support feasibility, site selection, and start-up activities, including submissions to Human Research Ethics Committees.
  • Negotiate site budgets and execute contracts.
  • Lead site initiation visits to train investigators and trial staff in protocol and data collection methods.
  • Conduct interim monitoring visits to ensure adherence to protocol, review participant source data, and perform Investigational Product accountability.
  • Closed-out visits and oversee study site management to ensure high-quality data.

Requirements:

  • Bachelor's degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals).
  • At least 3-4 years' experience in monitoring clinical trials in CRO, Pharmaceutical, and/or Biotechnology industry as a SCRA/CRA.
  • Experience in managing early phase oncology trials is highly preferred.
  • Experience in EDC & CTMS, contract negotiation, HREC submission preparation, and understanding of ICH-GCP requirements.
  • Willingness to travel for role requirements.

About Us:

We are a progressive and passionate team dedicated to designing care experiences that deliver the best possible life outcomes. Join us to design better care and enjoy a career with purpose.

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