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Clinical Research Associate - VIC

Clinical Research Associate - VIC

NovotechMelbourne, Australia
22 days ago
Job description

Join to apply for the Clinical Research Associate - VIC role at Novotech

The Clinical Research Associate (CRAII - CRAIII) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from source documents. The CRA is the primary contact between the Investigational Sites, Novotech, and Sponsor. Key responsibilities include site relationship management, compliance with ICH GCP guidelines, local and global regulatory requirements, and Novotech / Client SOPs.

Minimum Qualifications & Experience

  • Graduate in a clinical or life sciences-related field. Relevant experience / qualifications in allied professions may also be considered.
  • Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate.
  • Must have full unrestricted working rights in Australia. We unfortunately cannot provide sponsorship for this role.

Experience Levels

  • CRA II : minimum of 6 months of CRA independent monitoring experience.
  • CRA III : 2+ years of CRA independent monitoring experience.
  • Responsibilities

  • Build relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure efficient, expedited, and smooth trial management.
  • Foster internal and external customer relationships to focus on efficient, timely, and productive project delivery as per study requirements and timelines.
  • Collaborate with the In-house Clinical Research Associate (IHCRA) and Regulatory Start Up Associate (RSA) to prepare site essential documents and support ethics and regulatory submission and approval processes as needed.
  • Understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials.
  • Ensure recruitment of participants as per the site target and drive site recruitment and engagement initiatives.
  • Conduct monitoring of investigational sites as per ICH GCP, including all monitoring visit types across all phases of a clinical trial.
  • Benefits

  • Hybrid working arrangements with full flexibility in working hours to support work‑life balance.
  • Flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs, and ongoing development programs.
  • Novotech is proud to offer a great workplace committed to gender equality and an inclusive work environment where everyone is treated fairly and with respect. We welcome passionate people who identify as LGBTIQ+, have a disability, or have caring responsibilities.

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    Clinical Research Associate • Melbourne, Australia

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