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Clinical Operations Specialist
Career Insights for Scheduler / Operations Coordinator
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Based on California data
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What they do
A Scheduler or Operations Coordinator provides scheduling and logistical support for an office, company or organization. May specialize in scheduling required for production or for administrative work.
$62,913 / year median in California
+4% projected growth
Job Description
Clinical Operations Specialist A-Line Staffing Solutions
•4.0 Irvine, CA Job Details Full-time $35
•$40 an hour 1 day ago Qualifications Teamwork Procurement Regulatory compliance Schedule management Attention to detail Research compliance clinical trial records management Collaboration with manufacturing teams Biomedical regulatory compliance Associate's degree Cross-functional communication Time management Full Job Description
CLINICAL OPERATIONS SPECIALIST I
•
IRVINE, CA Pay Rate:
$35.00
•$40.00/hour
Schedule:
Monday
•Friday, 8:00 AM
•5:00
PM Work Arrangement:
Onsite Experience Required:
At least 2 years of clinical research experience
Location Preference:
Local candidates from Los Angeles or Orange County preferred
Pay Determination:
Final pay rate will be determined at the time of offer
JOB SUMMARY
The Clinical Operations Specialist I supports clinical research operations by developing and improving trial processes, coordinating clinical study devices and inventory, managing documentation, supporting financial activities, and ensuring compliance with applicable regulations and study requirements. This position works closely with clinical study teams and cross-functional partners to maintain efficient, accurate, and compliant clinical trial operations.
KEY RESPONSIBILITIES
Identify, develop, recommend, and implement moderately complex process development and process improvement solutions to optimize global clinical trial workflows and timelines. Develop and execute device-related processes associated with clinical trials while ensuring compliance with applicable regulations and study requirements. Manage the lifecycle of clinical trial devices and partner closely with Clinical Study Teams, Manufacturing Operations, Finance, Supply Chain, Quality, and Compliance teams. Lead and support continuous improvement initiatives designed to increase the efficiency and accuracy of clinical trial processes and procedures. Coordinate procurement of study inventory and manage the shipment of clinical trial devices to clinical sites within established timelines. Confirm receipt of study products at clinical sites and track products through final disposition. Ensure required documentation is completed and appropriately filed within the Trial Master File (TMF). Monitor internal device and study-specific inventory levels and support inventory forecasting and planning activities. Develop timeline assessments in collaboration with clinical stakeholders to support key study milestones and deadlines. Generate transparency reporting data and reports as needed to support Sunshine Act compliance. Track, manage, and coordinate clinical study invoice processing to ensure timely review, approval, and payment. Generate reports on outstanding clinical study invoice payments for review by clinical study teams. Ensure clinical study documentation is appropriately stored and archived within designated record retention facilities. Review clinical study files for accuracy and completeness and enter information into computerized tracking systems. File, scan, and archive clinical research documentation for multiple clinical trials. Support clinical research laboratory operations as needed. Perform other duties as assigned to support clinical study operations.
REQUIREMENTS
More than 2 years of clinical research experience. Strong understanding of clinical trial operations, documentation, and regulatory requirements. Ability to coordinate multiple clinical research activities while maintaining accuracy and established timelines. Strong organizational and time-management skills. Ability to collaborate effectively with clinical, quality, compliance, supply chain, finance, and other cross-functional teams. Strong attention to detail and ability to maintain accurate clinical study records. Ability to work onsite Monday through Friday, 8:00 AM
•5:00 PM.
EDUCATION
Associate's or Bachelor's degree in a related field preferred. If you are interested, please reach out to Chin Yang at A-Line Staffing.
INDJP Pay:
$35.00
•$40.00 per hour Expected hours: 40.0 per week
Work Location:
In person