TMF & Clinical Trials Administrative Coordinator

REVA Medical, Inc.; San Diego (CA); On-site; USD 55,000 - 75,000; Full time

Job summary

REVA Medical, Inc. is seeking an administrative support specialist for Clinical Affairs in San Diego. The role centers on TMF quality controls, regulatory document management, and meeting preparations for Investigator sessions.

Ideal candidates hold an undergraduate degree with 2-3 years of clinical trial experience and familiarity with TMF processes, MS Office, and document review. This entry crosses between coordinating with sites and supporting study teams.

Qualifications

• Undergraduate degree required.
• 2-3 years of relevant clinical trial experience.
• 1-2 years of electronic Trial Master File experience.

Responsibilities

• Perform quality checks, uploads and tracking of regulatory documents to populate the electronic TMF for designated studies.
• Obtain safety-related source documents and images from clinical sites for meeting packages; coordinate with translation vendors as needed.
• Track device inventory and prepare shipments to sites, ensuring device integrity and handling of expiring items.
• 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 action items.
• Assist with site invoicing and payment tracking.
• Assist with organization and filing of study-related materials.
• Assist in the organization and execution of Investigator meetings.
• Provide general administrative support as needed.

Skills

Attention to detail

Effective communication

Document management

Regulatory knowledge

Education

Undergraduate degree

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Adobe Acrobat

Job description

REVA Medical, Inc. is seeking an administrative support specialist for Clinical Affairs in San Diego. The role centers on TMF quality controls, regulatory document management, and meeting preparations for Investigator sessions.

Ideal candidates hold an undergraduate degree with 2-3 years of clinical trial experience and familiarity with TMF processes, MS Office, and document review. This entry crosses between coordinating with sites and supporting study teams.