Clinical Study Specialist

2 days ago

Sydney, New South Wales, Australia beBeeResearch Full time $98,765 - $123,456

Job Summary:

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As a seasoned Clinical Research Associate, you will be responsible for ensuring the seamless execution of clinical studies while upholding the highest standards of compliance with regulatory requirements. Your expertise in monitoring visits, reviewing study protocols, and preparing submissions to regulatory authorities will be invaluable in driving our research forward.

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Key Responsibilities:

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  • Conduct thorough on-site monitoring visits to ensure study conduct aligns with approved protocols and regulatory requirements">
  • Review and input study protocols, CRF documents, and validation tools to guarantee accuracy and completeness">
  • Prepare and review monitoring guidelines, CRF completion guidelines, and patient information documents to facilitate smooth communication">
  • Assist in preparing submissions to Independent Ethics Committees and Competent Authorities">
  • Collaborate with Investigator and Institution teams to negotiate budgets and arrange site payments">
  • Manage queries with the Clinical Data Management Team to resolve any discrepancies or concerns">
  • Support sites and study teams in managing external service provider contacts">
  • Participate in feasibility studies and Investigator selection to identify suitable candidates">
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Requirements:

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  • University degree in sciences or related fields">
  • At least 2 years of experience as a Clinical Research Associate in pharmaceutical companies or CROs">
  • Strong knowledge of relevant guidelines (e.g., ICH GCP) and regulatory requirements">
  • Fluent in English with excellent communication and organizational skills">
  • Ability to travel frequently">
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Ideal Candidate Profile:

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  • A team player with a strong sense of accountability and responsibility">
  • Excellent problem-solving and analytical skills">
  • Proven ability to work under pressure and meet deadlines">
  • Flexibility and adaptability in a fast-paced environment">

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