Clinical Operations Specialist 1 (Req 2Yrs Exp in Clinical Research) -Onsite

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

Job summary

MillenniumSoft Inc in Irvine, CA is seeking a Clinical Operations Specialist 1 for onsite, 1st shift. The role supports device process development and clinical trial workflow optimization, managing the life cycle of trial devices and ensuring regulatory compliance.

Responsibilities include coordinating procurement, maintaining TMF documentation, forecasting inventory, and collaborating with cross-functional teams across Manufacturing Operations, Finance, Quality, and Compliance.

Qualifications

• Must have 2+ years of clinical research experience or similar
• Onsite presence required, Monday–Friday, 8 AM–5 PM
• Experience with TMF or regulatory documentation is a plus

Responsibilities

• Identify, develop, and implement process improvements to optimize trial workflows
• Develop and execute device processes for clinical trials ensuring regulatory compliance
• Coordinate procurement and shipments of study inventory to sites
• Maintain and file documentation in TMF and related systems
• Monitor inventory levels and support forecasting and planning
• Track study invoices and support payments and reporting

Skills

Process development

Regulatory compliance

Cross-functional collaboration

Inventory forecasting

Documentation accuracy

Reporting skills

Education

Associate's or Bachelor's degree in related field

Job description

Position: Clinical Operations Specialist 1

Location: USA CA - Irvine Laguna Canyon, 17200 Laguna Canyon Road, Irvine California 92618

Category: Clinical

Labor Type: Clinical

Duration: 12 months

Total Hours/week: 40

Shift: 1st Shift

Pay rate: $35.00 - $40.00/hour

Job Summary

Specialist 1, Clinical Operations to support device process development and clinical trial workflow optimization in Irvine, CA. This role manages the life cycle of clinical trial devices, ensures regulatory compliance, and partners with cross-functional teams to improve process efficiency. This is an onsite position on 1st Shift.

Roles And Responsibilities

• Identify, develop, and implement process improvement solutions to optimize global trial workflow timelines
• Develop and execute device processes for clinical trials, ensuring regulatory compliance
• Partner with clinical study teams, Manufacturing Operations, Finance, Supply Chain, Quality, and Compliance groups
• Coordinate procurement of study inventory and manage device shipments to clinical sites
• Confirm receipt of study product at sites and track through to final disposition
• Ensure required documentation is filed in the Trial Master File (TMF)
• Monitor device and study-specific inventory levels; support forecasting and planning
• Develop timeline assessments to meet key study milestones and deadlines
• Generate transparency reporting data to support Sunshine Act compliance
• Track and coordinate clinical study invoice processing, review, approval, and payment
• Ensure proper documentation storage and archiving (e.g., Iron Mountain, clinicaltrials.gov)
• Review clinical study files for accuracy and completeness; maintain computerized tracking systems
• Support clinical research laboratory operations as needed

Experience

• 2 to 4 years of relevant experience
• Minimum of 2 years of clinical research experience required

Key Skills

• Process development and process improvement
• Device lifecycle management and regulatory compliance knowledge
• Cross-functional collaboration and stakeholder management
• Inventory forecasting and planning
• Documentation accuracy and computerized tracking systems
• Strong organizational and reporting skills

Eligibility And Qualifications

• Associate's or Bachelor's degree in a related field preferred
• Minimum 2 years of clinical research experience required
• Onsite presence required, Monday-Friday, 8 AM-5 PM
• No drug screening required for this assignment