Senior Clinical Research Associate (CRA)

Senior Clinical Research Associate (CRA) Full-time · On -site · Minneapolis, Minnesota, U.S. At TRiCares, we are dedicated to providing innovative, minimally invasive treatment solutions for patients suffering from failing tricuspid valves. As a growing MedTech company based in Munich, we are looking for a proactive and skilled Senior Clinical Research Associate to join our dynamic team and support us in our mission to improve patient care. This is a unique opportunity to join a growing medical device company, where you will be part of a passionate and international team working towards transforming the landscape of cardiovascular treatment through innovative technology. The Sr. CRA is responsible for managing and supporting assigned clinical trial sites participating in TRiCares' IDE pivotal study. This role serves as the primary point of contact for sites, partnering closely with investigators and study coordinators to d rive site activation, enrolment, study execution, and closeout. The Sr. CRA plays a key role in site performance, patient enrolment, data quality, and overall study success. Key Responsibilities: • Serve as the primary point of contact for assigned clinical sites, managing site relationships from activation through study closeout. • Lead site activation activities, including training, study start -up, and site readiness efforts. • Partner closely with investigators and study coordinators to drive enrolment, optimize site performance, and address operational challenges. • Monitor key site performance metrics, including activation timelines, enrolment, patient follow -up, data quality, and protocol compliance. • Support sites in maintaining complete, accurate, and inspection -ready study files and documentation. • Identify and proactively address enrolment barriers, protocol deviations, and operational risks. • Conduct site qualification, initiation, monitoring, and closeout visits as needed. • Review study data, source documents, and informed consent records to support quality and compliance. • Support investigator meetings, site training, and ongoing site engagement activities. • Collaborate with Clinical Affairs leadership to develop and implement strategies that improve site performance and study execution. • Provide regular updates on site performance, enrolment forecasts, risks, and mitigation plans. Qualifications and Experience : • Bachelor's degree in Life Sciences, Nursing, or a related field. • 5+ years of CRA or clinical research experience, including medical device clinical trials. • Experience managing multiple clinical sites and supporting study enrolment. • Strong knowledge of GCP , FDA regulations, and clinical trial operations. • Excellent organizational, communication, and problem -solving skills. • Ability to travel regularly to clinical sites. Preferred: • Experience with IDE or pivotal medical device studies. • Structural heart, cardiovascular, or transcatheter valve experience preferred. • Experience working directly with investigators, research coordinators, and site leadership. • Familiarity with CTMS, EDC, and eTMF systems. What We Offer: • A dynamic and forward -thinking work environment, shaping the future of transcatheter heart valve therapy • The opportunity to work in a truly international team, with talented and driven colleagues from around the globe • A strong company culture rooted in collaboration, innovation, and purpose • Excellent opportunities for personal and professional development in a fast -growing MedTech company • A competitive compensation and benefits package tailored to your experience and contribution • Regular team events and offsites to connect, celebrate successes, and foster team spirit • An inclusive and respectful workplace where diversity is not only welcomed but valued Ready to make a difference? We look forward to receiving your application. Join us on our journey to transform patient care - one heartbeat at a time. Apply now at: hr@tricares.de.