Medtronic is seeking to address the global epidemic of hypertension through the development and launch of Renal Denervation (RDN) therapy, a novel procedure that has the potential to transform healthcare in the United States and become a multibillion-dollar market globally. The company aims to bring this innovative therapy to patients with uncontrolled hypertension by ensuring successful clinical trials and regulatory approval.
Requirements
- Bachelor’s degree with 4+ years of clinical research/clinical (e.g. field clinical research/clinical specialist/field clinical engineer) experience
- Advanced degree with 2 years of clinical research/clinical (e.g. field clinical research/clinical specialist/field clinical engineer) experience
- Experience in Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials
- Certification from a Clinical Research Association (CCRP/CCRC)
- Experience at Medtronic or within the medical device industry
- Experience in the management of clinical devices
- Cardiovascular/cardiac rhythm management device training (e.g., pacemakers & defibrillators)
Responsibilities
- Provides field support for various clinical research studies by selecting sites, performing activation duties, setting up protocols, providing training, helping to enroll participants, supporting cases, ensuring quality data acquisition and performing study closure activities.
- Addressing clinical research site needs by maintaining frequent contact via email/phone/on-site visits with principal investigators, sub-investigators, and research coordinators.
- Responsible for gaining and maintaining knowledge of clinical sites in a given geographic area to best understand and assess investigators' interests and capabilities.
- Provides continuous communication to in-house clinical trial leaders regarding the status and performance of multiple studies.
- Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies.
- Interface with representatives from key functional groups (Monitoring, Data Management, Research & Development, Manufacturing, Sales, Marketing, Regulatory Affairs, Legal, and European Clinical groups).
- Identify and mitigate quality risks and issues for assigned clinical studies, with oversight from study management. Oversee follow-up and resolution of site issues.
Other
- Bachelor’s degree or advanced degree
- 50% - 75% travel required to enhance collaboration and ensure successful completion of projects
- Position is remote
- Must be independently mobile and able to interact with a computer and communicate with peers and co-workers
- Must be able to perform the essential functions of the job with or without reasonable accommodations
