Edwards Lifesciences Clinical Research Associate II - In House Transcatheter 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 In house Clinical Research Associate II will ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements.
Perform study start-up and conduct activities including ICF review that meets regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities
Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases
Conduct in-house and site (if applicable) reviews of associated documentation and participate in 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
Assess current processes, identify opportunities and propose solutions to improve process efficiency within and across related functional areas
Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution
Assist with clinicaltrials.gov updates
Required Experience :
A Bachelor's Degree
A minimum of three years experience with regulatory documentation for clinical studies
Preferred Experience :
- Medical device experience
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
Excellent written and verbal communication skills and interpersonal relationship skills
Excellent problem-solving and critical thinking skills
Solid knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
Solid 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 inter-departmental teams and representing the organization on specific projects
Ability to build productive internal/external working relationships
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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.