Freelance Clinical Trial Operations Jobs (NOW HIRING)

A-Line Staffing is now hiring a Full-Time, On-Site, Clinical Trial Operations Specialist in Irvine, CA!

We are seeking an experienced Clinical Operations Specialist I to join our team in Irvine, California. This position plays a critical role in supporting clinical trial operations, device management, inventory coordination, documentation, and process improvement initiatives.

The ideal candidate will have a strong background in clinical research operations and experience coordinating study devices, managing documentation, supporting cross-functional teams, and ensuring compliance throughout the clinical trial lifecycle.

Why This Role Is Important

The Clinical Operations Specialist I serves as a critical link between clinical research teams, manufacturing operations, supply chain, finance, quality, and regulatory departments.

Unlike traditional clinical research positions that focus exclusively on study coordination, this role emphasizes clinical device management throughout the entire clinical trial lifecycle. The selected candidate will oversee study devices from procurement and distribution through final disposition while ensuring compliance, documentation accuracy, inventory management, and adherence to regulatory requirements.

Clinical Trial Operations Specialist Compensation

·         The pay for this position is $35-40.00/hr

·         Benefits are available to full-time employees after 90 days of employment

·         A 401(k) with a company match is available for full-time employees with 1 year of service on our eligibility dates

Clinical Trial Operations Specialist Highlights

• This position is a contract assignment with potential to hire on permanently based upon attendance, performance, and business needs
• The required availability for this position Monday-Friday, 8:00 AM-5:00 PM

Clinical Trial Operations Specialist Responsibilities

·         Identify, develop, recommend, and implement process improvements to optimize global clinical trial workflows.

·         Develop and execute device management processes associated with clinical studies.

·         Partner with clinical study teams, manufacturing, supply chain, finance, quality, and compliance teams to ensure successful study execution.

·         Coordinate the procurement of study inventory and manage device shipments to clinical research sites.

·         Track study devices from distribution through final disposition while maintaining accurate documentation.

·         Confirm receipt of study products at clinical sites and ensure all required documentation is properly maintained within the Trial Master File (TMF).

·         Monitor device inventory levels and support inventory forecasting and planning activities.

·         Collaborate with stakeholders to develop timelines that support study milestones and project deadlines.

·         Generate transparency reporting data to support Sunshine Act compliance.

·         Track, manage, and coordinate clinical study invoice processing to ensure timely review, approval, and payment.

·         Prepare reports on outstanding invoices for review by clinical study teams.

·         Maintain and archive study documentation within record retention systems, including Iron Mountain and ClinicalTrials.gov.

·         Review clinical study files for accuracy and completeness.

·         Enter information into computerized tracking systems and prepare documentation for archiving.

·         Support clinical research laboratory operations as needed.

·         Perform additional duties to support clinical study operations.

Clinical Trial Operations Specialist Requirements

• Previous clinical trial experience is required.
• At least 2 years of clinical research experience.
• Experience supporting clinical trial operations.
• Experience managing study documentation and Trial Master Files (TMF).
• Experience coordinating study devices and clinical inventory.
• Strong organizational and documentation skills.
• Ability to work effectively in a cross-functional environment.
• Proficiency with computerized tracking systems and clinical documentation platforms.

Preferred Qualifications

• Associate's degree in a related field.
• Bachelor's degree in a related field.
• Experience with inventory forecasting and supply chain coordination.
• Knowledge of regulatory requirements related to clinical research.
• Experience supporting clinical laboratories

If you think this Clinical Trial Operations Specialist position is a good fit for you, please reach out to me—feel free to call, e-mail, or apply to this posting!