Medtronic — күрделі медициналық жағдайларға арналған шешімдер әзірлейтін жаһандық денсаулық сақтау технологиялары және өндіріс компаниясы. Оның қызметі емдеу тәсілдерін, терапияларды және медициналық технологияларға қолжетімділікті жақсарту үшін ірі халықаралық командаларды медицина мамандарымен тығыз ынтымақтастықта біріктіреді. 150-ден астам елде 95 000-нан көп қызметкері бар Medtronic пациенттерге көрсетілетін көмекті дамытуға назар аудара отырып, өз қызметінің барлық бағыттарында инклюзияны, әртүрлілікті, теңдікті және тұрақты тәжірибелерді қолдайды.
Senior Clinical Research Monitor (CRA)
Oversee medical device clinical trials for Medtronic, managing site monitoring, compliance, investigator relationships, and study delivery.
Сипаттама
- 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.
Талаптар
- 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.
Артықшылықтар
- Competitive salary and flexible benefits package.
- Short-term incentive through the Medtronic Incentive Plan (MIP).