Clinical Research Specialist

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

Job Position: Clinical Operations Specialist

Duration: 12 months

Location: Irvine CA 92618

Job Description:

• Identify, develop, recommend, and implement, moderately complex process development and process improvement solutions to optimize global trial workflow timelines, (e.g., device return aging issues, status of open device issues/queries, etc.)
• Develop and execute device processes associated with clinical trials.
• Ensure compliance with regulations and manage the lifecycle of devices, while closely partnering with other internal key stakeholders ( e.g., clinical study teams, Manufacturing Operations, Finance, Supply Chain, Quality, and Compliance groups) to develop and lead the execution of the device process, and ensuring continuous process improvement of efficiency and accuracy of processes and procedures.
• Verify inventory and process device shipment to clinical sites within our shipping timeframe to Customer Service, Trade Compliance, and other relevant stakeholders.
• Confirm receipt of product with the clinical site and obtain copies of signed and dated packing slips. Monitor device inventory by coordinating with Supply Chain and Clinical Specialists
• Develop timeline assessments (e.g., transition to new device system, system enhancements to meet supply and demand, etc) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines.
• Ensure documentation are archived appropriately within record retention facility (e.g., Iron Mountain, clinicaltrial.gov)
• Track, manage, and coordinate clinical study invoice processing to ensure timely review, approval, and payment.
• Generate reports on outstanding invoice payments for clinical study team review
• Review and ensure accuracy and completeness of clinical study files, enter into computerized tracking system, and file/scan for archive, for multiple clinical research trials
• Support clinical research laboratory operations as needed
• Other incidental duties as assigned

Required:

• 1–2 years of patient-facing experience in a clinical research, healthcare, or related medical setting.

Preferred experience/qualifications:

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