Edwards Lifesciences Senior Clinical Research Associate (Senior Specialist) - Hybrid In House/Monitor - TMTT in Irvine, California
This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease.
The Senior Specialist, Clinical Research Associate will ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements. This role is a hybrid Senior CRA responsible for mentoring in house clinical research associates in Irvine, Ca and having 40% travel to field sites nationwide.
Responsible for study start-up and study conduct activities including drafting ICF study specific template and TMF plan, approving study specific essential documents list, managing and communicating the status of study progress and activities
Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution. Oversee the work of the Sr Representative and may provide coaching and training to lower level employees
Lead in the investigation of all discrepancies in study documentation, by applying clinical protocol knowledge and GCP and develop processes to mitigate reoccurrence throughout study phases
Lead in assessing current and new processes, identifying opportunities and implementing solutions to improve process efficiency within and across related functional areas
Conduct in-house and site (if applicable) reviews of associated documentation and lead in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure documents are compliant with Good Documentation Practices and Edwards internal SOPs, and US and OUS regulations
Partner with clinical project manager in leading regular team meetings
Prepare materials for steering and investigator meetings
Other incidental duties
Travel may be up to 40% nationwide as needed
Bachelor's Degree in related field required
5 years of previous experience with regulatory documentation for clinical studies required
Ability to travel up to 40% nationwide as needed
- Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file)
Additional Skills and Responsibilities:
Written and verbal communication skills and interpersonal relationship skills
Excellent problem-solving and critical thinking skills
knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
Full 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 key contact representing the organization on contracts or projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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 13,000 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.