Clinical Operations Specialist 1 (Req 2Yrs Exp in Clinical Research) -Onsite

About the role

Clinical Operations Specialist 1 to support device process development and clinical trial workflow optimization in Irvine, CA. This role manages the life cycle 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.

Responsibilities

• 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

Experience

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

Key skills

• 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

Qualifications

• Associate's or Bachelor's degree in a related field preferred
• Minimum 2 years of clinical research experience required
• Onsite presence required, Monday-Friday, 8 AM-5 PM