Medtronic je globalno podjetje na področju zdravstvenih tehnologij in proizvodnje, ki razvija rešitve za kompleksna zdravstvena stanja. Njegovo delo povezuje velike mednarodne ekipe in tesno sodelovanje z zdravstvenimi strokovnjaki za izboljšanje zdravljenja, terapij in dostopa do medicinske tehnologije. Z več kot 95.000 zaposlenimi v več kot 150 državah se Medtronic osredotoča na napredek pri oskrbi pacientov ter hkrati podpira vključevanje, raznolikost, enakost in trajnostne prakse v vseh svojih dejavnostih.
Senior Clinical Research Monitor (CRA)
Oversee medical device clinical trials for Medtronic, managing site monitoring, compliance, investigator relationships, and study delivery.
Opis
- Manage site monitoring from qualification and initiation through interim visits and closeout.
- Act as the main sponsor contact for assigned sites, building working relationships with investigators, coordinators, hospitals, and research institutions.
- Keep studies conducted, documented, and reported in line with protocols, GCP, regulatory requirements, and Medtronic procedures.
- Review source records, study data, protocol deviations, adverse events, and site performance to protect patient safety and data quality.
- Help launch sites by supporting feasibility reviews, ethics submissions, investigator documentation, and activation requirements.
- Prepare investigators and site staff on protocols, investigational devices, study procedures, and compliance expectations.
- Support recruitment, retention, and study delivery through active site management and performance oversight.
- Contribute to clinical development, process improvements, study planning, and cross-functional teams.
Zahteve
- Bachelor’s degree and at least 4 years of relevant experience, or an advanced degree and at least 2 years of relevant experience.
- Experience conducting on-site and remote monitoring visits across multiple clinical studies.
- Knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and clinical research regulations.
- Experience using Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and Microsoft Office applications.
- Experience managing investigator relationships, site performance, and clinical trial delivery throughout the study lifecycle.
- Preferred: 5 years of clinical monitoring experience.
- Preferred: Experience monitoring medical device clinical trials.
- Preferred: Experience with site feasibility, ethics submissions, activation, and study start-up.
- Preferred: Experience reviewing adverse events, protocol deviations, and risk-based monitoring metrics.
- Preferred: Experience mentoring Clinical Research Associates (CRAs) or supporting study team development.
- Preferred: Knowledge of Australian and global clinical research regulations and requirements.
Ugodnosti
- Competitive salary and flexible benefits package.
- Short-term incentive through the Medtronic Incentive Plan (MIP).