Clinical Operations Specialist 1

Roles & Responsibilities

• 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, clinicaltrials.gov)
• Review clinical study files for accuracy and completeness; maintain computerized tracking systems
• Support clinical research laboratory operations as needed

Experience Required

• 2 to 4 years of relevant experience
• Minimum of 2 years of clinical research experience required

Skills & Certifications

• 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

Eligibilities & qualifications

• Associate\'s or Bachelor\'s degree in a related field preferred
• Minimum 2 years of clinical research experience required
• Onsite presence required, Monday - Friday, 8 AM- 5 PM
• No drug screening required for this assignment