Clinical Trials Operations Specialist (12-Month Contract)

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 for a 12-month contract on W2. The role is 1st shift, Mon-Fri, 8am-5pm, with 40 total hours per week.

Pay rate ranges from $35 to $40 per hour and will be determined at time of offer. Responsibilities include developing and optimizing trial workflows, coordinating study inventory, ensuring TMF documentation, and supporting audit-ready processes across internal teams such as Manufacturing Operations, Finance, Supply

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 improvement for global trial workflow timelines.
• Coordinate procurement of study inventory and manage shipment to clinical sites within established timelines.
• Confirm receipt of study product at clinical sites and track through final disposition with TMF documentation.
• Monitor internal device and study-specific inventory levels and assist with forecasting and planning.
• Generate and review reports to support Sunshine Act compliance and clinical study invoicing.

Skills

Clinical Research

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 for a 12-month contract on W2. The role is 1st shift, Mon-Fri, 8am-5pm, with 40 total hours per week.

Pay rate ranges from $35 to $40 per hour and will be determined at time of offer. Responsibilities include developing and optimizing trial workflows, coordinating study inventory, ensuring TMF documentation, and supporting audit-ready processes across internal teams such as Manufacturing Operations, Finance, Supply