Device Trial Operations Specialist (Clinical)

MillenniumSoft Inc; Irvine (CA); On-site; USD 73,000 - 83,000; Full time

Job summary

MillenniumSoft Inc in Irvine, CA is seeking a Clinical Research Specialist 1 for a 12-month contract on 1st shift, 40 hours per week. Onsite position with a pay rate of $35–$40 per hour, to be determined at offer stage.

The role focuses on developing and implementing process improvements for global trial workflows, coordinating device-related activities, TMF documentation, and invoice management while ensuring regulatory compliance of device trials.

Qualifications

• 2 years of clinical research experience.
• Associate's/Bachelor's degree in a related field.

Responsibilities

• Identify, develop, recommend, and implement moderately complex process development and process improvement solutions to optimize global trial workflow timelines.
• Develop and execute device processes associated with clinical trials, ensuring regulatory compliance and lifecycle management of devices.
• Coordinate procurement of study inventory and manage shipment of devices to clinical sites within established timelines.
• Confirm receipt of study product at clinical sites and track through to final disposition, filing TMF documentation.
• Monitor internal device and study-specific inventory levels; support inventory forecasting and planning; develop timeline assessments with stakeholders to meet milestones.
• Generate transparency reporting data and reports as needed to support Sunshine Act compliance.
• Track, manage, and coordinate clinical study invoice processing and report outstanding payments.
• Ensure documentation are stored and archived appropriately within record retention facilities.
• Review and ensure accuracy and completeness of clinical study files and enter into tracking systems.
• Support clinical research laboratory operations as needed.
• Other incidental duties as assigned to support clinical study operations.

Education

Associate's/Bachelor's degree in a related field

Job description

MillenniumSoft Inc in Irvine, CA is seeking a Clinical Research Specialist 1 for a 12-month contract on 1st shift, 40 hours per week. Onsite position with a pay rate of $35–$40 per hour, to be determined at offer stage.

The role focuses on developing and implementing process improvements for global trial workflows, coordinating device-related activities, TMF documentation, and invoice management while ensuring regulatory compliance of device trials.