Clinical Trial Coordinator

WHO WE ARE

We are a growing medical device company developing innovative technology to transform the treatment of mitral valve disease. Our team is advancing a transcatheter mitral valve replacement through pivotal clinical development, with a shared commitment to bringing safe, effective, and innovative technology to patients.

THE OPPORTUNITY

We are seeking a Clinical Coordinator to provide critical coordination and operational support across our Clinical Operations team. This is a highly collaborative role that touches many aspects of clinical trial execution—from site documentation and clinical data to payments, device logistics, meetings, and training.

The ideal candidate is organized, detail-oriented, and comfortable managing multiple priorities while ensuring clinical trial activities remain accurate, timely, and audit-ready.

HOW YOU WILL CONTRIBUTE

Clinical Documentation & Site Support

• Independently track and maintain, site regulatory documentation; including but not limited to regulatory approvals, informed consent, agreements, and reporting requirements.
• Independently track and maintain, site personnel documentation; including but not limited to CVs, trainings, and credentials for study site personnel.
• Independently track and maintain, investigational device accountability and trial procedure documentation.
• Serve as a point of contact for clinical sites on documentation and subject matter expert on documentation.
• Maintain accurate, audit-ready study files in electronic systems.
• Regularly conduct internal review of trial documents maintained by the Sponsor.

Payments & Financial Tracking

• Process payments, invoices, and compensation for sites, core labs, and additional third-party vendors.
• Review invoices according to executed agreements to ensure accuracy. Collaborate with internal and external staff to reconcile financial discrepancies to ensure timely and accurate payment processing.
• Track and maintain payments and provide accrual information to Finance.
• Serve as subject matter expert for internal and external staff for all trial payments and financial tracking.

Device & Trial Materials Logistics Coordination

• Support operations with device & trial materials shipments, returns, and documentation.
• Maintain accurate records of device & trial materials disposition and returns.
• Coordinate with Operations on shipping logistics.
• Independently assemble, maintain, and distribute internal and external trial materials (e.g., subject binders, regulatory binders, recruitment materials).

Meeting & Training Support

• Assist in coordinating investigator, study coordinator, and committee meetings (on-site and remote).
• Assist with travel and logistics when supporting meetings.
• Prepare training materials, track attendance, and engage with site personnel.

General Team Support

• Provide cross-coverage to support other coordinators as workloads shift.
• Contribute to process improvements and team initiatives as needed.

Image & Data Processing

• Coordinate receipt, processing, and tracking of clinical images and related data from sites and core labs.
• Resolve issues with sites and vendors to ensure timely and complete data submissions.
• Maintain image data records in EDC and ensure quality and compliance.

Perform other duties as required for successfully completing studies, as necessary.