Clinical Ops Specialist: Trials & Device Processes

Indotronix Avani Group; Irvine (CA); On-site; USD 60,000 - 85,000; Full time

Job summary

Indotronix Avani Group seeks a Clinical Operations Specialist for a 12-month assignment in Irvine, CA. The role targets process development and optimization of global trial workflows and device processes within clinical studies.

You will collaborate with study teams, Manufacturing Operations, Finance, Supply Chain, Quality, and Compliance to ensure device lifecycle management, regulatory compliance, inventory accuracy, and timely invoicing.

Qualifications

• 1–2 years of patient-facing experience in a clinical research, healthcare, or related medical setting.
• Association's/Bachelor's degree in a related field preferred.

Responsibilities

• Identify, develop, and implement moderately complex process development and improvement to optimize global trial workflow timelines.
• Develop and execute device processes associated with clinical trials.
• Ensure regulatory compliance and manage the lifecycle of devices with cross-functional teams.
• Verify inventory and process device shipment to clinical sites within shipping timeframe.
• Monitor device inventory and coordinate with Supply Chain and Clinical Specialists.
• Develop timeline assessments to meet study milestones and deadlines.
• Archive documentation in record retention facilities and systems.
• Track and coordinate clinical study invoice processing and payments.
• Generate reports on outstanding invoice payments for the clinical study team.
• Review and ensure accuracy of clinical study files and archival processes.
• Support clinical research laboratory operations as needed.

Skills

Patient-facing experience

Education

Associate's/Bachelor’s degree

Job description

Indotronix Avani Group seeks a Clinical Operations Specialist for a 12-month assignment in Irvine, CA. The role targets process development and optimization of global trial workflows and device processes within clinical studies.

You will collaborate with study teams, Manufacturing Operations, Finance, Supply Chain, Quality, and Compliance to ensure device lifecycle management, regulatory compliance, inventory accuracy, and timely invoicing.