What are the responsibilities and job description for the Associate Specialist, Clinical Safety, Critical Care, Irvine Ca position at Edwards Lifesciences LLC?
The Critical Care Associate Specialist of Clinical Safety will 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:
• Review of adverse event notifications and source documents received from the investigational sites or from the electronic database to assess whether Serious Adverse Event (SAE) criteria are met per protocol definition
• Evaluate the need for medical records independently to support further review for medical reviewers and CEC/IMR adjudication
• Assist medical reviewers in submitting potential reportable event to Complaint Handling Department and provide source documents needed for further review, in accordance with regulatory requirements, safety processes and Edwards procedures
• Identify and investigate discrepancies in documentation by applying clinical protocol knowledge and develop processes to prevent recurrence
• Assess current processes, identify opportunities and propose solutions to improve process efficiency within and across related functional areas
• Assist in-house and site (if applicable) reviews of associated documentation and participate in internal and FDA audits to ensure all essential clinical safety files are compliant in accordance with Good Clinical Practice, Edwards internal SOPs and all other regulatory bodies.
• Create (1%) and manage (4%) in-house tracking systems and workflow process to improve safety processes
• Other incidental duties
Education and Experience:
Bachelor's Degree in biological or Lifesciences field required. 1 Year experience previous hands-on clinical research related experience Required
Experience with an ERP software, CTMS (Clinical Trial Management System) and Patient Tracking system Preferred
Additional Skills:
• Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery
• Good written and verbal communication skills and interpersonal relationship skills
• Demonstrated 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 studies
• Good 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 immediate supervisor and other team members in the section or group
• Ability to build stable working relationships internally
• 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.
