Medtronic is seeking to address universal healthcare needs and improve patients' lives, specifically in the area of Coronary & Renal Denervation therapies, by introducing a new therapy that will potentially transform healthcare in the United States.
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.
Other
- 50% - 75% travel to enhance collaboration and ensure successful completion of projects
- Bachelor’s degree
- Advanced degree
- 4+ years of experience
- 2 years of experience
