Edwards Lifesciences Clinical Research Associate I - In House Study management - Trancatheter Heart Valve Unit - Irvine, Ca in Irvine, California
This is an exciting opportunity within a company that leads the heart valve market, not only in terms of market share but also in cutting edge technology. The Transcatheter Heart Valve (THV) team extends Edwards’s leadership into the transcatheter area, providing immediate new treatment alternatives to patients with no or few other alternatives, eventually positioning THV as the treatment of choice for aortic stenosis.
The Clinical Research Associate I will ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements.
Essential Job Functions:
· Participate in study start-up activities (e.g., tracking site readiness, communication with clinical trial sites about planning and logistics of site qualification visit and site initiation visit).
· Conduct reviews of documentation needed for internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards internal SOPs, and US and OUS regulations.
· Investigate discrepancies and participate in the development of processes to minimize possibility of recurrence during study conduct and closeout.
· Assist in identifying opportunities and proposing solutions to improve process efficiency within and across related functional areas.
· Assist with administrative activities
· May be mentored under close supervision on field monitoring of studies and data collection for clinical trials
Minimum Education/Experience Required:
Bachelor’s Degree in related field, 1 year of previous experience with regulatory documentation for clinical studies.
· Good computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred.
· Good written and verbal communication skills and interpersonal relationship skills.
· Good problem-solving and critical thinking skills.
· Good knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols.
· Good understanding of regulatory submissions, reporting, and audits.
· Ability to manage confidential information with discretion.
· Strict attention to detail.
· Ability to interact professionally with all organizational levels.
· Ability to manage competing priorities in a fast paced environment.
· Must be able to work in a team environment, including immediate supervisor and other team members in the section or group.
· Ability to build productive internal/external working relationships.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.