Contract Clinical Research Specialist - Device Trial Ops

MillenniumSoft Inc; Irvine (CA); In loco; USD 48.000 - 55.000; Tempo pieno

Descrizione del lavoro

MillenniumSoft Inc. is seeking a Clinical Research Specialist 1 in Irvine, CA. This contract position (12 months) is on the 1st shift, 40 hours per week, with a $35–$40/hr W2 arrangement.

The role focuses on managing device-related processes for clinical trials, coordinating inventory, TMF documentation, and ensuring regulatory compliance. Ideal candidates have 2+ years of clinical research experience and an Associate’s or Bachelor’s degree in a related field.

Competenze

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

Mansioni

• Identify, develop, and implement moderately complex process development and improvement solutions to optimize trial workflows.
• Develop and execute device-related processes for clinical trials, coordinating with study teams, Manufacturing, Finance, Supply Chain, Quality and Compliance.
• Coordinate procurement and shipment of study inventory to clinical sites within timelines.
• Confirm receipt of study product at sites and track to final disposition, filing TMF documentation.
• Monitor inventory levels and assist with forecasting to meet study milestones.
• Produce transparency reports for Sunshine Act compliance as needed.
• Track and coordinate invoice processing and payments, reporting on outstanding invoices.
• Archive documentation in record retention facilities (e.g., Iron Mountain, clinicaltrial.gov).
• Review accuracy of clinical study files, enter into tracking systems, and scan/archive files.
• Support clinical research laboratory operations as needed.
• Perform other duties to support study operations.

Conoscenze

Clinical research

Process development

Process improvement

Formazione

Associate's degree

Bachelor's degree

Descrizione del lavoro

MillenniumSoft Inc. is seeking a Clinical Research Specialist 1 in Irvine, CA. This contract position (12 months) is on the 1st shift, 40 hours per week, with a $35–$40/hr W2 arrangement.

The role focuses on managing device-related processes for clinical trials, coordinating inventory, TMF documentation, and ensuring regulatory compliance. Ideal candidates have 2+ years of clinical research experience and an Associate’s or Bachelor’s degree in a related field.