Job Description
Job Description
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.
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!