Clinical Operations Specialist I

Clinical Operations Specialist I

Pay Range: $30hr - $35hr

The Clinical Operations Specialist I will support clinical trial device processes, workflow optimization, and operational coordination across clinical study teams and cross-functional stakeholders. The role involves managing clinical device lifecycle activities, ensuring regulatory compliance, tracking inventory and shipments, and supporting continuous process improvement for clinical research operations.

Requirement/Must Have:

• 12 years of patient-facing experience in a clinical research, healthcare, or related medical setting.

Experience:

• Experience supporting clinical research or healthcare operations is required.

Responsibilities:

• Identify, develop, recommend, and implement process development and improvement solutions to optimize clinical trial workflows.
• Develop and execute device-related processes associated with clinical trials.
• Ensure compliance with regulations and manage the lifecycle of clinical trial devices.
• Collaborate with clinical study teams, manufacturing operations, finance, supply chain, quality, and compliance groups.
• Verify inventory and process device shipments to clinical sites within required timelines.
• Confirm receipt of products with clinical sites and obtain signed and dated packing slips.
• Monitor device inventory in coordination with supply chain and clinical specialists.
• Develop timeline assessments to support study milestones and transitions to new systems or enhancements.
• Ensure proper documentation archiving within record retention systems.
• Track and manage clinical study invoice processing to ensure timely review and payment.
• Generate reports on outstanding invoice payments for clinical study team review.
• Review clinical study files for accuracy and completeness and maintain electronic tracking systems.
• Support clinical research laboratory operations as needed.
• Perform other incidental duties as assigned.

Should Have:

• Experience in clinical trial operations or device management preferred.
• Familiarity with healthcare or clinical research environments.

Skills:

• Strong organizational and coordination skills.
• Ability to work with cross-functional teams.
• Attention to detail and documentation accuracy.
• Strong communication skills.

Qualification And Education:

• Associates or Bachelors degree in a related field preferred.