Clinical Research Administrative Specialist (TMF)

REVA Medical, LLC.; San Diego (CA); On-site; USD 39,000 - 47,000; Full time

Job summary

REVA Medical, LLC. is seeking an organized Clinical Trial Master File Coordinator to manage TMF documentation for designated studies and ensure audit readiness for regulatory filings.

The role involves gathering safety-related documents, coordinating with translation vendors, tracking device inventory, and supporting study supply distribution to CROs and clinical centers. Strong communication and detail orientation are essential.

Qualifications

• Minimum 1-2 years of clinical study electronic Trial Master File experience.
• Proficient with basic computer programs such as Microsoft Word, Excel PowerPoint and Adobe Acrobat.
• Detail oriented in document review and error checking.
• Effective communication skills.

Responsibilities

• Perform quality checks, uploads and tracking of TMF documents for designated studies.
• Generate reports of missing documents and upcoming expiration dates.
• Communicate with sites and study team to obtain required documents.
• Ensure the TMF is audit-ready for regulatory filings.
• Obtain safety-related source documents for meeting packages; coordinate translations as needed.
• Track device inventory and prepare shipments to sites with proper temperature control and expiry handling.
• Assist with distribution and tracking of study supplies to CROs and clinical centers.
• Interface with CROs to obtain study-related documentation and follow up on actions.
• Assist site invoicing and payment tracking.
• Help organize and file study materials and Investigator meetings.

Skills

TMF experience

Attention to detail

Effective communication

MS Office familiarity

Education

Undergraduate degree

2-3 years clinical trial experience

Tools

Microsoft Word

Excel

PowerPoint

Adobe Acrobat

Job description

REVA Medical, LLC. is seeking an organized Clinical Trial Master File Coordinator to manage TMF documentation for designated studies and ensure audit readiness for regulatory filings.

The role involves gathering safety-related documents, coordinating with translation vendors, tracking device inventory, and supporting study supply distribution to CROs and clinical centers. Strong communication and detail orientation are essential.