Clinical Operations Specialist

Indotronix Avani Group; Irvine (CA); On-site; USD 60,000 - 90,000; Full time

Job summary

Indotronix Avani Group is seeking a Clinical Operations Specialist for a 12-month engagement in Irvine, CA. The role focuses on developing and executing device processes for clinical trials, ensuring regulatory compliance, and coordinating with cross-functional teams to meet study milestones.

The candidate should have patient-facing experience in clinical research or healthcare settings and hold an Associate's or Bachelor's degree. This position requires on-site work in Irvine, CA 92618.

Qualifications

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

Responsibilities

• Identify and implement device process improvements to optimize global trial workflow timelines.
• Develop and execute device processes for clinical trials.
• Ensure compliance with regulatory requirements and manage device lifecycle with key stakeholders.
• Verify inventory and ship devices to clinical sites within shipping timelines.
• Coordinate with Supply Chain to monitor device inventory and tracking.
• Develop timeline assessments with stakeholders to meet study milestones.
• Archive documentation in retention facilities (e.g., Iron Mountain).
• Process clinical study invoices and generate payment reports.
• Review clinical study files for accuracy and archive appropriately.

Skills

Patient-facing experience

Clinical research

Healthcare setting

Quality/compliance

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.
• Maintains current and active licensure and certification(s) to administer First Aid, BLS and CPR for emergent needs in healthy volunteer clinical research studies.
• Support clinical research laboratory operations as needed.

Required:

• >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.