Senior Clinical Research Associate

5 days ago

Auckland, Auckland, New Zealand Mobius Medical Full time NZ$80,000 - NZ$120,000 per year

Company Description

Mobius Medical is a boutique, full-service clinical research partner with a global presence including operations in the United States, Australia, and New Zealand. The company is known for its regulatory expertise across jurisdictions and specialises in early phase clinical research, enabling simultaneous site activations globally. Mobius Medical provides tailored clinical trial management services, from strategic design and monitoring to clinical report production. With ISO:9001-certified Quality Management Systems, cost-effective in-house Electronic Data Capture (EDC) solutions, and compliance with global regulatory requirements, Mobius Medical ensures high-quality and efficient clinical trial processes.

Role Description

You will support the Australian clinical team, by managing and monitoring 3 sites – Auckland, Wellington and Hamilton, New Zealand, ensuring compliance to the protocol and local regulations. You will have a minimum of 3 years' experience of CRA experience at a CRO or industry. You can easily illustrate a thorough understanding of complex pharmaceutical clinical study designs, hold an appreciation of key stakeholders such sponsors, site staff, third parties, your Mobius colleagues and possess a thorough knowledge of New Zealand regulatory requirements.

Main tasks

  • General clinical trials management tasks from feasibility and site selection to all start-up tasks
  • Conduct site visits including interim monitoring and close-out
  • Collaborate with Management to maintain and report on your site management tasks
  • Ensure sites comply with the protocol, all SOPs and study plans
  • Build and maintain excellent rapport with site staff
  • Troubleshoot and find compliant solutions to issues
  • Hold regular project meetings with the Project Manager, Sponsor, and assist with status reporting
  • Maintain training / professional development needs

Role requirements

  • Minimum Bachelor's degree in life science or related field.
  • Verbal and written high proficiency in English language.
    3+ years of experience in a clinical research role
  • Thorough practical knowledge of ICH GCP
  • Ability to lead and work in a team
  • Solution/goal oriented
  • Trustworthy timekeeper and diligent maintenance of records
  • Excellent communicator (verbal, written and presentation skills)

Available to start:

ASAP.

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