Clinical Ops Specialist I: Trials & Process Optimization

MillenniumSoft Inc; Irvine (CA); On-site; USD 100,289,000 - 114,616,000; Full time

Job summary

MillenniumSoft Inc in Irvine, CA seeks a Specialist 1, Clinical Operations for a 12-month on-site assignment. Hours are Mon-Fri, 8am-5pm; pay rate is $35-$40/hr and will be determined at offer. The role supports device workflow, inventory control and study documentation across clinical trials.

You will coordinate study inventory, ensure TMF filing, and collaborate with clinical teams to meet milestones. At least 2 years in clinical research is required.

Qualifications

• Minimum 2 years of clinical research experience required.
• Experience developing and implementing device-related trial processes.
• Strong documentation and regulatory compliance focus.

Responsibilities

• Identify, develop and implement moderately complex process improvements for trial workflows.
• Develop and manage device processes for clinical trials with internal stakeholders.
• Coordinate procurement and shipment of study devices to sites on schedule.
• Ensure TMF documentation is complete and archived properly.
• Monitor inventory levels, forecast needs, and support milestone planning.
• Generate reports for Sunshine Act compliance and study invoicing.

Skills

Clinical research

Process improvement

Device processes

Inventory management

Documentation

Education

Associate's degree

Bachelor's degree

Job description

MillenniumSoft Inc in Irvine, CA seeks a Specialist 1, Clinical Operations for a 12-month on-site assignment. Hours are Mon-Fri, 8am-5pm; pay rate is $35-$40/hr and will be determined at offer. The role supports device workflow, inventory control and study documentation across clinical trials.

You will coordinate study inventory, ensure TMF filing, and collaborate with clinical teams to meet milestones. At least 2 years in clinical research is required.