Medtronic este o companie globală de tehnologie medicală și producție, care dezvoltă soluții pentru afecțiuni medicale complexe. Activitatea sa reunește echipe internaționale numeroase și o colaborare strânsă cu profesioniștii din domeniul sănătății pentru a îmbunătăți tratamentele, terapiile și accesul la tehnologia medicală. Cu peste 95.000 de angajați în mai mult de 150 de țări, Medtronic se concentrează pe dezvoltarea îngrijirii pacienților, susținând totodată incluziunea, diversitatea, echitatea și practicile sustenabile în cadrul operațiunilor sale.
Senior Clinical Research Monitor (CRA)
Oversee medical device clinical trials for Medtronic, managing site monitoring, compliance, investigator relationships, and study delivery.
Descriere
- 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.
Cerințe
- 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.
Beneficii
- Competitive salary and flexible benefits package.
- Short-term incentive through the Medtronic Incentive Plan (MIP).