Clinical Operations Associate Analyst

4 weeks ago

Irvine, United States Cypress HCM Full time
Job DescriptionJob Description
Clinical Operations Associate AnalystWe have an exciting opportunity for a Clinical Operations Associate Analyst position with one of the top medical device companies in the country. Responsibilities:
  • Identify, develop, recommend, and implement, moderately complex process development and process improvement solutions to optimize global trial workflow timelines, (e.g., device return aging issues, status of open device issues/queries, etc.)
  • Develop and execute device processes associated with clinical trials. Ensure compliance with regulations and manage the lifecycle of devices, while closely partnering with other internal key stakeholders ( e.g., clinical study teams, Manufacturing Operations, Finance, Supply Chain, Quality, and Compliance groups) to develop and lead the execution of the device process, and ensuring continuous process improvement of efficiency and accuracy of processes and procedures.
  • Verify inventory in JDE and process device shipment to clinical sites within our shipping timeframe to Customer Service, Trade Compliance, and Warehouse. Confirm receipt of product with the clinical site and obtain copies of signed and dated packing slips. Monitor device inventory by coordinating with Supply Chain and Clinical Specialists
  • Develop timeline assessment (e.g., transition to new device system, system enhancements to meet supply and demand, etc) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines.
  • Lead the validation of systems to incorporate the use of clinical system into clinical studies and act as a liaison to ensure adherence to procedures in collaboration with internal (e.g., Study Management) and external (e.g., vendors) stakeholders
  • Ensure documentation are archived appropriately within record retention facility (e.g., Iron Mountain, clinicaltrial.gov)
  • Provide clinical compliance knowledge and determine learning requirements within the learning management system, training plans, study specific training matrices, and study rosters. Analyze and identify internal training deficiencies, as needed.
  • Review and ensure accuracy and completeness of clinical study files, enter into computerized tracking system, and file/scan for archive, for multiple clinical research trials
  • Support clinical research laboratory operations as needed
  • Other incidental duties as assigned.
Skills and Experience:
  • Bachelor's Degree
  • 0-2 years of experience preferred.
  • Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
  • Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint
  • Good written and verbal communication skills and interpersonal relationship skills
  • Experience with an ERP software, JDE and CTMS (Clinical Trial Management System) preferred
  • Ability to work in a fast paced environment
  • Substantial knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical study documentation
  • Good problem-solving skills
  • Ability to manage confidential information with discretion
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • 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.
Compensation:
  • $28.59 to $38.12 per hour.

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