- Provide technical, educational, and clinical case support expertise to assist in meeting clinical study and investigator training objectives.
- Support clinical investigators who are using Occlutech products within IDE clinical research programs.
- Help in designing and conducting protocol and device training programs for Occlutech studies at clinical sites.
- Provide technical assistance during clinical study procedures and provide on-site case support with Occlutech products.
- Support clinical trials at assigned sites including the responsibility of site management by coordinating all activities pertaining to qualification and initiation of and ongoing site support for the clinical trial.
- Provide clinical trial education and training for physicians, hospital personnel and office staff on study related documents and devices in support of Occlutech clinical trials.
- Perform site training activities in compliance with GCP in conjunction with FDA, EU MDR, Health Canada and any other applicable regulations for clinical trials.
- Partner with the study team and the study sites to support study enrollments.
- Document problems related to investigational devices.
- Submit periodic status reports on all study programs and activities.
- Submit case summary reports and site visit training reports in a timely manner.
- Review and provide feedback on clinical strategy and protocols.
- Identify and screen potential clinical investigators.
- Develop clinical site relationships.
- Interface with representatives from key functional groups including but not limited to R&D, Marketing, Regulatory, and International Clinical teams to drive success of clinical programs on as-needed basis.
- Develop training programs and modules for training purposes.
- Demonstrate a commitment to patient safety and product quality by maintaining compliance with all quality system requirements.
- Travel of approximately 50-75% required. Occasional weekend travel may be needed.
- Perform other job-related duties as assigned.
- Healthcare experience: Registered Nurse, Cardiac Sonographer, CVT, Radiologic Technologist (RT), EMT, RCIS or the like required.
- Minimum of 5 years' experience scrubbing or image supporting in an interventional (cardiac catheterization/Electrophysiology lab) setting or operating room preferred.
- Preferred minimum of 2-3 years medical device or pharmaceutical clinical trial experience.
- Strong clinical knowledge base in anatomy, physiology, neurovascular, and/or cardiology/interventional terminology.
- Ability to develop strong relationships with investigator base including study coordinators, physicians, and cath lab staff.
- Understanding of, and experience in, clinical trial processes.
- Strong interpersonal skills to demonstrate products and procedures clearly and concisely.
- Ability to make group presentations.
- Ability to interact with Occlutech employees, especially R&D, clinical and marketing, to represent the investigator perspective.
- Independent, self-motivated, self-starter.
- Skills in strategic thinking, problem solving, planning and time-management.
- Ability to express ideas clearly and succinctly.
- Ability to interpret clinical data.
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Field Clinical Specialist - Minnesota, United States - Occlutech US LLC
4 weeks ago
Description
Occlutech is the leader in developing innovative products for the treatment of structural heart disease. The Company manufactures, develops, sells and markets Class III medical devices for the transcatheter repair of structural heart defects, including a range of specialized devices for patients with atrial fibrillation or heart failure, in over 90 markets around the world. Occlutech operates facilities in Germany, Turkey and Sweden.
Your work will focus on:
Required Skills & Experience:
