Clinical Trials Specialist

4 days ago

Alton Downs, Australia beBeeResearch Full time $90,000 - $120,000

Job Title: Senior Clinical Research Associate

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The Senior Clinical Research Associate plays a pivotal role in ensuring the smooth conduct of clinical trials, upholding stringent standards of protocol compliance, ICH guidelines and regulatory requirements.

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Key Responsibilities:

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  • Conduct Site Qualification Visits to verify that trial staff and facilities adhere to protocol specifications.">
  • Support Feasibility Studies, site selection, and start-up activities to ensure seamless trial execution.">
  • Negotiate site budgets and facilitate the execution of site contracts with expertise.">
  • Perform Site Initiation Visits to train Investigators and other trial staff on the protocol and data collection methodologies.">
  • Carry out Interim Monitoring Visits to verify adherence to protocol and oversee participant source data.">
  • Oversee all aspects of study site management to guarantee high-quality data integrity.">
  • Maintain eTMF Filing and study tracking in Clinical Trial Management System (CTMS).">
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Requirements:

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  • Possess an undergraduate degree in Life Sciences, such as Biology, Chemistry or Pharmaceuticals.">
  • Hold at least 3-4 years' experience in monitoring clinical trials within the CRO, Pharmaceutical and/or Biotechnology industry as a SCRA/CRA.">
  • Experience in managing early phase oncology trials is highly preferred.">
  • Display practical knowledge of ICH-GCP requirements particularly for site management.">

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