Clinical Operations Specialist

Indotronix Avani Group; Irvine (CA); On-site; USD 60,000 - 80,000; Full time

Job summary

Indotronix Avani Group is seeking a candidate in Irvine, California to improve clinical trial processes and manage device inventory. Responsibilities include developing solutions for workflow optimization, ensuring regulatory compliance, and tracking clinical study invoices.

The ideal candidate must hold an Associate's/Bachelor’s degree in a related field and have patient-facing experience in a clinical research or healthcare setting. Current CPR and First Aid certification is required.

Qualifications

• Experience in a patient-facing role in clinical research or healthcare settings.
• Current CPR and First Aid certification from an accredited provider.

Responsibilities

• Develop and implement process improvement solutions for clinical trials.
• Ensure compliance and manage the lifecycle of trial devices.
• Coordinate inventory and shipment of devices to clinical sites.

Skills

Process improvement

Clinical trial management

Inventory management

Regulatory compliance

Education

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

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 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 time frame 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 to meet key study milestones and deadlines.
• Ensure documentation is archived appropriately within the record retention facility (e.g., Iron Mountain, clinicaltrials.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 the computerized tracking system, and file/scan for archive, for multiple clinical research trials
• Maintains current and active licensure and certification(s) to administer First Aid, BLS, and CPR for emergent needs in healthy volunteer clinical research studies

Required

• Associate's/Bachelor’s degree in a related field
• Patient-facing experience in a clinical research, healthcare, or related medical setting.
• Current CPR and First Aid certification from an accredited provider