Clinical Operations Specialist 1 (Req 2Yrs Exp in Clinical Research) Onsite
Job Location:
Irvine, CA - USA
Hourly Salary:
Posted:
Application Deadline:
Vacancies:
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Job Summary
Position: Clinical Operations Specialist 1
Location: USA CA - Irvine Laguna Canyon 17200 Laguna Canyon Road Irvine California 92618
Category: Clinical
Labor Type: Clinical
Duration: 12 months
Total Hours/week: 40
Shift: 1st Shift
Job Summary
Specialist 1 Clinical Operations to support device process development and clinical trial workflow optimization in Irvine CA. This role manages the life cycle of clinical trial devices ensures regulatory compliance and partners with cross-functional teams to improve process efficiency. This is an onsite position on 1st Shift.
Identify develop and implement process improvement solutions to optimize global trial workflow timelines
Develop and execute device processes for clinical trials ensuring regulatory compliance
Partner with clinical study teams Manufacturing Operations Finance Supply Chain Quality and Compliance groups
Coordinate procurement of study inventory and manage device shipments to clinical sites
Confirm receipt of study product at sites and track through to final disposition
Ensure required documentation is filed in the Trial Master File (TMF)
Monitor device and study-specific inventory levels; support forecasting and planning
Develop timeline assessments to meet key study milestones and deadlines
Generate transparency reporting data to support Sunshine Act compliance
Track and coordinate clinical study invoice processing review approval and payment
Ensure proper documentation storage and archiving (e.g. Iron Mountain )
Review clinical study files for accuracy and completeness; maintain computerized tracking systems
Support clinical research laboratory operations as needed
2 to 4 years of relevant experience
Minimum of 2 years of clinical research experience required
Process development and process improvement
Device lifecycle management and regulatory compliance knowledge
Cross-functional collaboration and stakeholder management
Inventory forecasting and planning
Documentation accuracy and computerized tracking systems
Strong organizational and reporting skills
Associates or Bachelors degree in a related field preferred
Minimum 2 years of clinical research experience required
Onsite presence required MondayFriday 8 AM5 PM
No drug screening required for this assignment
Required Experience:
IC
