Clinical Trials Operations Specialist

A-Line staffing is hiring a Clinical Trials Operations Specialist in Irvine, CA. The Clinical Trials Operations Specialist would be working for a Fortune 500 Biomedical company.

If interested APPLY NOW for IMMEDIATE consideration!!

Clinical Trials Operations Specialist Job Details

• Pay Range: $30-$35/hour
• Location: Irvine, CA 92618 (100% onsite)
• Shift: Monday – Friday 8am-5pm PST
• Education: High School Diploma or equivalent required. Degree is highly preferred.

Position Summary:

The Clinical Operations Specialist supports clinical trial device operations and trial workflow execution by improving processes, coordinating cross-functional stakeholders, managing device lifecycle activities, and supporting documentation/invoicing workflows to ensure studies meet key milestones and compliance requirements.

Clinical Trials Operations Specialist Responsibilities

• 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).
• Develop and execute device processes associated with clinical trials.
• Ensure compliance with regulations and manage the lifecycle of devices; partner closely with internal stakeholders (Clinical Study Teams, Manufacturing Operations, Finance, Supply Chain, Quality, Compliance) to execute device processes and drive continuous improvement for efficiency and accuracy.
• Verify inventory and coordinate device shipments to clinical sites within required shipping timeframes; partner with Customer Service, Trade Compliance, and other stakeholders as needed.
• Confirm receipt of product with clinical sites and obtain signed/dated packing slips; monitor device inventory in coordination with Supply Chain and Clinical Specialists.
• Develop timeline assessments (e.g., transitions to new device systems, system enhancements to meet supply/demand) in collaboration with clinical stakeholders to meet study milestones and deadlines.
• Ensure documentation is archived appropriately within record retention facilities/systems (e.g., Iron Mountain, clinicaltrial.gov).
• Track, manage, and coordinate clinical study invoice processing to support timely review, approval, and payment.
• Generate reports on outstanding invoice payments for clinical study team review.
• Review clinical study files for accuracy/completeness; enter into tracking systems; file/scan for archival across multiple clinical research trials.
• Maintain current licensure and certifications to administer First Aid, BLS, and CPR for emergent needs in healthy volunteer clinical research studies.
• Support clinical research laboratory operations as needed.

Clinical Trials Operations Specialist Qualifications:

• 1–2+ years of patient-facing experience in clinical research, healthcare, or a related medical setting
• 2+ years in a clinical role such as EMT or Medical Assistant
• Associate’s or Bachelor’s degree in a related field Highly preferred (or equivalent experience will be considered)
• Current CPR / First Aid certification from an accredited provider

If interested in this Clinical Trials Operations Specialist position, APPLY NOW to Chris Meyer for IMMEDIATE consideration!!