Device Clinical Trials Specialist I – Irvine (Contract)

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

Job summary

MillenniumSoft Inc. in Irvine, CA seeks a Clinical Research Specialist 1 for a 12-month contract on W2. The role focuses on clinical trial device processes, regulatory compliance, and collaboration with study teams, manufacturing, quality, and finance to drive trial timelines.

The position is Mon-Fri, 8am-5pm, 40 hours/week, with a pay rate of $35-$40 per hour. First shift, on-site in Irvine. Requires 2 years of clinical research experience and an associated degree.

Qualifications

• 2 years of clinical research experience.
• Associate's or 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. Ensure compliance with regulations and manage the lifecycle of devices, while partnering with internal stakeholders to execute the device process.
• 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 required documentation are filed in the Trial Master File (TMF).
• Monitor internal device and study-specific inventory levels; support inventory forecasting and planning with clinical stakeholders.
• Generate transparency reporting data to support Sunshine Act compliance.
• Track, manage, and coordinate clinical study invoice processing; generate reports on outstanding payments.

Skills

Clinical research experience

Education

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

Job description

MillenniumSoft Inc. in Irvine, CA seeks a Clinical Research Specialist 1 for a 12-month contract on W2. The role focuses on clinical trial device processes, regulatory compliance, and collaboration with study teams, manufacturing, quality, and finance to drive trial timelines.

The position is Mon-Fri, 8am-5pm, 40 hours/week, with a pay rate of $35-$40 per hour. First shift, on-site in Irvine. Requires 2 years of clinical research experience and an associated degree.