Clinical Research Specialist I — Device Trial Ops

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

Job summary

MillenniumSoft Inc in Irvine, CA invites applications for a Clinical Research Specialist 1. This is a 12-month contract on W2, 1st shift, 40 hours/week, with pay rate $35-$40 per hour.

Employment eligibility follows the posting requirements (US Citizens, GC Holders, or equivalent work authorization). The role involves developing and implementing process improvements to streamline global trial workflows, coordinating study inventory and shipments, tracking TMF documentation, supporting invoicing

Qualifications

• Minimum 2 years of clinical research experience.
• Bachelor’s or Associate degree in a related field.

Responsibilities

• Identify, develop, and implement moderately complex process development and process improvement solutions to optimize global trial workflow timelines.
• 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 until final disposition; ensure TMF documentation is filed.
• Monitor internal device and study-specific inventory levels; support forecasting and planning.
• Generate transparency reporting data and reports for Sunshine Act compliance.
• Track and coordinate clinical study invoice processing; generate reports on outstanding payments.
• Ensure documentation is stored and archived in retention facilities (e.g., Iron Mountain, clinicaltrial.gov).
• Review study files for accuracy and enter into tracking systems; file/scan for archive.

Education

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

Job description

MillenniumSoft Inc in Irvine, CA invites applications for a Clinical Research Specialist 1. This is a 12-month contract on W2, 1st shift, 40 hours/week, with pay rate $35-$40 per hour.

Employment eligibility follows the posting requirements (US Citizens, GC Holders, or equivalent work authorization). The role involves developing and implementing process improvements to streamline global trial workflows, coordinating study inventory and shipments, tracking TMF documentation, supporting invoicing