Clinical Trials Expert

2 days ago

Sydney, New South Wales, Australia beBeeExpertise Full time $200,000 - $250,000

Clinical Trials Expert

We are seeking an experienced Clinical Trials Expert to join our team. The successful candidate will be responsible for monitoring clinical trials and ensuring that projects are conducted in accordance with applicable SOPs, regulations, and ICH guidelines.

Key Responsibilities:
  • Monitor clinical trials to ensure compliance with SOPs, regulations, and ICH guidelines
  • Perform site qualification visits to discuss protocol, study documentation, and requirements with investigators and trial staff
  • Support feasibility, site selection, and start-up activities, including preparation of Human Research Ethics Committee submissions
  • Negotiate site budgets and assist with the execution of site contracts
  • Perform site initiation visits to train investigators and trial staff on protocol and data collection methods
  • Perform interim monitoring visits to ensure adherence to protocol and monitor participant source data via source document verification
  • Perform site close-out visits
Required Skills and Qualifications:
  • Undergraduate 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
  • Experience in all aspects of site-management from feasibility, start-up site selection to site close-out
  • Experience in contract negotiation desirable
  • Experience in HREC submission preparation
  • Understanding and practical knowledge of ICH-GCP requirements particularly as required for site management
Benefits:
  • Opportunities to work directly with sponsors on assigned projects
  • Internal and external training and development opportunities
  • Enhance your holistic wellbeing with our Full Circle wellbeing program
  • Range of benefits available: Qantas membership discount, Anytime Fitness Gym membership discount, paid parental leave
About the Role:

This is a fantastic opportunity to join a highly progressive and passionate team of healthcare professionals and support staff united by a common purpose: to design care experiences that deliver the best possible life outcomes.

The role offers excellent career growth opportunities, a dynamic work environment, and a competitive salary package.

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