Clinical Operations Specialist

Clinical Operations Specialist

Location: Irvine, CA 92618 Work Location: Onsite Employment Type: Contract Duration: 12 months (possibility to extension / FTE)

The Specialist 1, Clinical Operations will support clinical research activities, device management, trial processes, documentation, inventory, and operational coordination. This role will work closely with clinical study teams and cross-functional groups to ensure clinical trial activities are completed accurately, efficiently, and within established timelines.

Key Responsibilities

• Identify, develop, recommend, and implement moderately complex process improvements to optimize clinical trial workflows and timelines.
• Develop and execute device-related processes associated with clinical trials while ensuring compliance with applicable regulations.
• Manage the lifecycle of clinical trial devices and coordinate with Clinical, Manufacturing, Finance, Supply Chain, Quality, and Compliance teams.
• Coordinate procurement of study inventory and shipment of devices to clinical sites within established timelines.
• Confirm receipt of study products at clinical sites and track devices through final disposition.
• Ensure required clinical trial documentation is properly maintained within the Trial Master File (TMF).
• Monitor study-specific device and inventory levels and support inventory forecasting and planning.
• Develop timeline assessments with clinical stakeholders to support study milestones and deadlines.
• Generate transparency reporting data and reports to support Sunshine Act compliance.
• Track and coordinate clinical study invoice processing, including review, approval, and payment status.
• Generate reports on outstanding clinical study invoices for review by the clinical study team.
• Ensure clinical documentation is properly stored and archived according to record-retention requirements.
• Review clinical study files for accuracy and completeness and enter information into computerized tracking systems.
• Support filing, scanning, and archiving activities for multiple clinical research trials.
• Support clinical research laboratory operations as needed.
• Perform other duties as assigned to support clinical study operations.

Required Qualifications

• At least 2 years of clinical research experience.
• Strong interest in clinical operations and clinical research.
• Ability to work onsite Monday–Friday, 8:00 AM–5:00 PM.

Preferred Qualifications

• Associate’s or Bachelor’s degree in a related field.
• 2+ years of experience in clinical research or clinical study operations.
• Experience working with clinical trial documentation, device management, inventory, or study coordination is a plus.
• Strong organizational and communication skills.
• Ability to coordinate with multiple cross-functional teams and manage timelines and documentation accurately.

Candidate Preference

• Local candidates preferred, particularly candidates located in Los Angeles County or Orange County.
• Candidates with 2+ years of clinical research experience who are interested in an entry-level role on the sponsor side are encouraged to apply.