Edwards Lifesciences Sr Spec, Clinical Safety in Irvine, California
Assure adverse events are reviewed and handled in accordance with regulatory requirements (FDA, IRB, EC and Other Regulatory Bodies), and with EW procedures and ethical standards to ensure patient safety in clinical trials.
Key Responsibilities: • Provide oversight on all safety processes from the site to the CEC to ensure process flow is managed efficiently and effectively • Develop training programs and metrics for safety team knowledge in collaboration with management to optimize the application of knowledge and performance • Analyze medical records received from enrolling sites to identify AEs (Adverse Events), SAEs (Serious Adverse Events) or UADEs (Unanticipated Adverse Device Effects) to confirm protocol definition and propose recommendations to site • Develop and write medical narratives from multiple sources of adverse event reporting and/or complaint review forms in order to facilitate safety officers and CEC review in accordance to regulatory requirements, trial safety processes, and EW procedures • Educate and provide training to enrolling sites to ensure protocol requirements are followed • Provide guidance and direction to lower level staff • Other incidental duties
Education and Experience: Bachelor's Degree in biological or Lifesciences field or Nursing degree, 5 years experience previous hands-on clinical research related experience Required Master's Degree or equivalent in Related field or MD Preferred
Additional Skills: • Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery • Experience with an ERP software (e.g JDE), CTMS (Clinical Trial Management System) and Patient Tracking system preferred • Excellent written and verbal communication skills and interpersonal relationship skills • Demonstrated problem-solving and critical thinking skills • Full knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies • Full understanding of medical terminology as it relates to clinical safety • Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g iMedidata) • 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.