Clinical Research Specialist - Device Trial Operations

MillenniumSoft Inc; Irvine (CA); In loco; USD 73.000 - 83.000; Tempo pieno

Descrizione del lavoro

MillenniumSoft Inc in Irvine, CA is seeking a Clinical Research Specialist 1 for a 12-month contract on W2. The role is 1st shift, 40 hours per week, Mon-Fri 8am-5pm.

You will support clinical trial workflows and device processes, coordinating inventory and TMF activities. Responsibilities include inventory management, invoice processing, regulatory compliance, and collaboration with study teams to meet milestones.

Competenze

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

Mansioni

• Identify, develop, and implement process development and improvement solutions to optimize trial timelines.
• Coordinate procurement of study inventory and manage shipment to sites.
• Confirm receipt of study product at sites and track to final disposition in the TMF.
• Monitor inventory levels and support forecasting to meet milestones.
• Generate reports for Sunshine Act compliance and study invoicing.
• Ensure documentation is stored and archived in designated facilities.

Conoscenze

Process development

Process improvement

Clinical research

Inventory forecasting

TMF management

Formazione

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

Descrizione del lavoro

MillenniumSoft Inc in Irvine, CA is seeking a Clinical Research Specialist 1 for a 12-month contract on W2. The role is 1st shift, 40 hours per week, Mon-Fri 8am-5pm.

You will support clinical trial workflows and device processes, coordinating inventory and TMF activities. Responsibilities include inventory management, invoice processing, regulatory compliance, and collaboration with study teams to meet milestones.