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Senior Clinical Research Monitor (CRA)

medtronic · Richmond

New
Onsite Senior 🇬🇧 English
Clinical Trial Management Systems (CTMS) Electronic Data Capture (EDC) Microsoft Office Good Clinical Practice (GCP)

Job description

About the role

Medtronic is looking for a Senior Clinical Research Monitor (CRA) to join its Clinical Research and Medical Science function in Melbourne, Australia. The role acts as the sponsor representative, overseeing clinical trial execution at assigned investigational sites from start-up through closeout, working across multiple therapy areas and medical device technologies. It is an onsite position with some travel required to support site monitoring, investigator engagement and study execution.

Key responsibilities

  • Lead site monitoring throughout the study lifecycle, including site qualification, initiation, interim monitoring and closeout visits.
  • Serve as the primary sponsor contact for assigned sites and build relationships with investigators, study coordinators, hospitals and research institutions.
  • Ensure studies follow protocols, GCP, regulatory requirements and Medtronic procedures.
  • Review source documentation, study data, protocol deviations, adverse events and site performance to protect patient safety and data integrity.
  • Support site start-up, including feasibility assessments, ethics submissions, investigator documentation and site activation.
  • Train investigators and site personnel on protocol requirements, investigational devices, study procedures and compliance.
  • Drive patient recruitment and retention, and contribute to clinical development, process improvement and study planning.

Required profile

  • Bachelor's degree with at least 4 years of relevant experience, or an advanced degree with at least 2 years.
  • On-site and remote monitoring experience across multiple studies.
  • Experience with GCP, ICH guidelines and clinical research regulations.
  • Preferred: 5 years of clinical monitoring, medical device trial experience, site start-up support, adverse event review, mentoring CRAs and knowledge of Australian and global regulations.

Required skills

  • Clinical Trial Management Systems (CTMS)
  • Electronic Data Capture (EDC)
  • Microsoft Office

What we offer

  • Competitive salary and a flexible benefits package.
  • Eligibility for the Medtronic Incentive Plan (MIP).

Questions fréquentes

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Source : ats:workday

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Published 1 day ago

Expires 1 month from now

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medtronic

Richmond