Clinical Research Associate II
Insightec is a growing medical technology company transforming patient lives through innovative incisionless surgery.Our culture is as unique as our people, a diverse global team, with different ideas, skills, interests, and cultural backgrounds driven by our core values – Our Patients, Integrity, Team, Quality and Innovation.Our dedication to making a real impact on the lives of millions of people and paving the path to a bright future for healthcare, is what bonds us as a Team. We work together in a dynamic collaborative environment to deliver successfully while believing and driving a life-work balance philosophy that encourages our employees to do things that are meaningful outside of work. Every role is significant, your voice is heard, and your ideas are encouraged. We challenge and empower our people to be great at what they do while providing a flexible work environment.Walking through our corridors, you will be inspired by stories of career journeys at Insightec. We take pride in growing internal talent and encourage our employees to achieve their professional ambitions. With employees in Israel - Haifa and K. Ono, Miami and Dallas, Shanghai, Tokyo and Europe, we offer in each region competitive perks and benefits.Do the most meaningful work of your career by joining us on our mission to transform tomorrows, today.Location: US (Remote)Responsibilities:Conduct site qualification, initiation, monitoring and closeout visits and create documentation of such through accurate and detailed visit reportsMonitor source documents to EDC for completeness and accuracy through verification of subject records and source documentation. Verify that all subjects meet inclusion/exclusion criteriaReview of all source records for patient safety and ensure complete documentation of all subject safety eventsReview regulatory binder to ensure complete, accurate, and up-to-date regulatory compliance at the siteTrain site personnel on study procedures and provide documentation of training. Ensure that study personnel are qualified by experience and training to perform assigned tasksFollow through after visit to outstanding requests/needs are fulfilled.Ensure compliance with protocol and overall clinical objectivesRaise issues of significance to the appropriate level for resolutionEnsure investigator involvement in the study and IRB/EC oversightResponsible for accurate and timely oversight and maintenance of TMF Apply tot his job