Clinical Research Specialist — Device Trial Operations

MillenniumSoft Inc; Irvine (CA); On-site; USD 48,000 - 55,000; Full time

Job summary

MillenniumSoft Inc. in Irvine, CA is seeking a Clinical Research Specialist 1 to support device-related clinical trials and ensure timely workflow execution. The role focuses on developing and implementing device processes, coordinating trial inventories, and maintaining required documentation.

The candidate should have at least 2 years of clinical research experience and an Associate's or Bachelor's degree. This contract position runs 12 months, with a 40-hour week on the first shift.

Qualifications

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

Responsibilities

• Identify, develop, 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 and ensure compliance with regulations, partnering with internal stakeholders.
• 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 final disposition; ensure documentation are filed in the Trial Master File (TMF).
• Monitor internal device and study-specific inventory levels; support inventory forecasting and planning; develop timeline assessments to meet milestones.
• Generate transparency reporting data and reports to support Sunshine Act compliance.
• Track, manage, and coordinate clinical study invoice processing to ensure timely review, approval, and payment; generate reports on outstanding invoices.
• Ensure documentation are stored and archived appropriately within record retention facilities (e.g., Iron Mountain, clinicaltrial.gov).
• Review and ensure accuracy and completeness of clinical study files, enter into computerized tracking system, and file/scan for archive.
• Support clinical research laboratory operations as needed.
• Other incidental duties as assigned to support clinical study operations

Skills

Clinical research

Process development

Device processes

Regulatory compliance

Documentation

Education

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

Job description

MillenniumSoft Inc. in Irvine, CA is seeking a Clinical Research Specialist 1 to support device-related clinical trials and ensure timely workflow execution. The role focuses on developing and implementing device processes, coordinating trial inventories, and maintaining required documentation.

The candidate should have at least 2 years of clinical research experience and an Associate's or Bachelor's degree. This contract position runs 12 months, with a 40-hour week on the first shift.