Clinical Operations Specialist

Clinical Operations Specialist

Location: Irvine, CA 92618 Work Location: Onsite Employment Type: Contract Duration: 12 months (possibility to extension / FTE) Schedule: Monday–Friday, 8:00 AM–5:00 PM Experience: 2+ years of clinical research experience

Job Summary

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.