.About Us: CorFlow is a Swiss med-tech start-up founded in 2016 by renowned interventional cardiologists and medical device entrepreneurs.The company recently completed a major financing round which enables the expansion of the clinical program and employee team.At CorFlow, we envision being the leader in diagnostic and therapeutic solutions for restoring healthy microvascular blood flow anywhere in the human body where a critical need exists.We are developing a medical device that assesses Microvascular Obstructions (MVO) in real-time during PCI and serves as a treatment platform while the patient is still in the cath lab.Our mission is rooted in scientific excellence and driven by compassion for the welfare of Acute Coronary Syndrome (ACS) patients.CorFlow's 1st generation device has been investigated in a First-in-Human multi-center European clinical trial, and CorFlow recently finished the development of the 2nd generation device which can be used in the next clinical studies.We seek a Senior Clinical Research Associate (SCRA) or Senior Field Clinical Trial Specialist (SFCTS) to support our Europe-based clinical activities, including proctoring, technical case support, and study management tasks for current and future trials.CorFlow is initiating a FDA pivotal trial which will have sites internationally, as well as a second randomized study that will be conducted exclusively in Europe.Job Description: The position includes a diverse set of duties.
In addition to your critical role in overseeing and managing clinical trials, you will take on advanced proctoring responsibilities.As a Proctor, you will train study site staff on the correct use of the study device and provide input during live cath lab procedures.
Periodic technical case support at investigator sites is also expected to ensure safe and effective use of the CorFlow technology, meeting study protocols.If you are a proactive, collaborative, service-minded, and detail-oriented individual with a passion for advancing medical research and a proven track record in medical device clinical trials, we encourage you to apply.Key Responsibilities Proctoring and Case Support Duties Train assigned study staff on the correct use of the study device.Supervise/support the setup of the required site workflow to ensure ideal basis for enrolment and that study images and measurements are collected and of consistent quality.Maintain detailed proctoring records and documentation.Assist remotely or on site during live cases by supporting site staff in the correct use of the CorFlow study device and the CIP.In agreement with CPM, release clinical sites to independent use of the study device.Clinical Trial Support Manage clinical trial activities in alignment with the clinical project manager (CPM), from study initiation, enrolment to study close-out