Clinical Safety Specialist (Surgical Structural Heart)

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: May 24, 2023

Job Description:

We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. Clinical Safety Specialist (Surgical Structural Heart) page is loaded Clinical Safety Specialist (Surgical Structural Heart) Apply locations USA - California - Irvine time type Full time posted on Posted 2 Days Ago job requisition id Req-24646 Edwards has an exciting opportunity with our Surgical Structural Heart group, focused on transforming patients' lives by advancing surgical structural heart innovations.The Clinical Safety Specialist will assure adverse events are reviewed and handled in accordance with regulatory requirements (FDA, IRB, EC and Other Regulatory Bodies), and with Edwards Lifesciences procedures and ethical standards to ensure patient safety in clinical trials, including communication with Investigational Sites, Complaint Reporting and Source Documents collection. - Position location: Onsite - Irvine, California (open to Hybrid) Key Responsibilities

• 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 procedure
• Evaluate packets from source documents to ensure accuracy for event adjudication to CEC (Clinical Event Committee)
• Identify and report Clinical Complaints from reported AE/or DD and provide updates and source documents for the relevant cases.
• Communicate with investigational sites and collect source documents needed for AE review/CH reporting and CEC adjudication.
• Other incidental duties related to safety and clinical research activities. Minimum Qualifications
  • Bachelor's degree in Biological, Lifesciences or Nursing with 3 years of hands-on clinical research experience (such as CRA, patient management, monitoring, clinical safety, liaison)
  • Ability to travel up to 15% for conferences and/or site visits.
  • Local or ability to relocate to Orange County Preferred Qualifications
    • Cardiovascular experience
    • Medical Device Project Management experience
    • Full understanding of medical terminology as it relates to clinical safety.
    • Experience with an ERP software, CTMS (Clinical Trial Management System).
    • iMedidata Rave
    • Certified Clinical Research Professional (CCRP)
      Additional Skills:
      • Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery.
      • Excellent written and verbal communication skills and interpersonal relationship skills.
      • Demonstrated problem-solving and critical thinking skills.
      • 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 company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.For California, the base pay range for this position is $81,000 to $114,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination RequirementEdwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements. About Us 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.

Keywords: Edwards Lifesciences Gruppe, Irvine , Clinical Safety Specialist (Surgical Structural Heart), Healthcare , Irvine, California