Clinical Operations Specialist 1

Specialist 1, Clinical Operations to support device process development and clinical trial workflow optimization in Irvine, CA. This role manages the lifecycle of clinical trial devices, ensures regulatory compliance, and partners with cross-functional teams to improve process efficiency. This is an onsite position on 1st Shift.

2 positions available.

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• Identify, develop, and implement process improvement solutions to optimize global trial workflow timelines
• Develop and execute device processes for clinical trials, ensuring regulatory compliance
• Partner with clinical study teams, Manufacturing Operations, Finance, Supply Chain, Quality, and Compliance groups
• Coordinate procurement of study inventory and manage device shipments to clinical sites
• Confirm receipt of study product at sites and track through to final disposition
• Ensure required documentation is filed in the Trial Master File (TMF)
• Monitor device and study-specific inventory levels; support forecasting and planning
• Develop timeline assessments to meet key study milestones and deadlines
• Generate transparency reporting data to support Sunshine Act compliance
• Track and coordinate clinical study invoice processing, review, approval, and payment
• Ensure proper documentation storage and archiving (e.g., Iron Mountain, clinicaltrials.gov)
• Review clinical study files for accuracy and completeness; maintain computerized tracking systems
• Support clinical research laboratory operations as needed

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• 2 to 4 years of relevant experience
• Minimum of 2 years of clinical research experience required

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• Process development and process improvement
• Device lifecycle management and regulatory compliance knowledge
• Cross-functional collaboration and stakeholder management
• Inventory forecasting and planning
• Documentation accuracy and computerized tracking systems
• Strong organizational and reporting skills