Clinical Trial Coordinator

About the role

The Clinical Trial Coordinator will support the management of clinical trial activities, focusing on document inspection, filing, and auditing, as well as managing study budgets and invoices.

Job Responsibilities

• Supports Trial Management Filing (TMF) system by inspecting, filing, and auditing documents.
• Assists in study budget negotiations and contract finalization with study providers, scientific committee members, and investigator sites.
• Serves as a key facilitator and liaison for shipping, receiving, and managing study devices and equipment.
• Reviews and tracks study invoices, manages study and site materials, and reviews informed consents.
• Ensures documentation is reconciled to demonstrate compliance with Standard Operating Procedures (SOPs) and regulations.
• Provides feedback for process improvements to the direct line manager.
• Supports project teams through matrix reporting, providing administrative and technical assistance as needed.
• May assist with study monitoring at clinical sites as required.

Qualification Requirements

• Analytical: Ability to analyze diverse information and inform product-specific directions.
• Design: Generates creative solutions and demonstrates attention to detail.
• Problem Solving: Skilled in gathering and analyzing information, developing solutions, and working in group problem-solving situations.
• Organizational Support: Supports the organization's goals and values.
• Adaptability & Dependability: Adapts to changes, manages competing demands, and maintains commitment to standards.
• Innovation: Displays original thinking, generates suggestions for improvement, and develops innovative approaches.
• Motivation: Sets and achieves challenging goals, demonstrates persistence, and measures performance against excellence.
• Demonstrated Ability: Proven experience managing multiple complex clinical projects.

Skills

• Oral Communication: Speaks clearly and persuasively, listens, and presents data effectively.
• Written Communication: Writes clearly and informatively, presents data accurately.

Pre-requisites / Job Experience

• Bachelor’s-level degree required, preferably in a science/health-related field (e.g., Biology, Nursing, Biomedical, Pharmacy, or Veterinary Sciences).
• 1-3 years’ experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials.

Physical Requirements

• Light lifting.
• Moderate computer usage.
• Extended periods of sitting or standing.
• Required in-office support in Irvine, CA (must live within driving distance).
• ~20% domestic travel.

Work Environment

• May be remote with occasional requirements to travel to Balt and/or clinical research sites and/or conferences.
• Working conditions are normal for an office environment.

Benefits

Not specified.

Pay

$80,000 - $85,000 USD

Benefits

Not specified.

Schedule

Not specified.