Clinical Research Assistant

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

Summary Of Essential Duties And Responsibilities

• Perform quality checks, uploads and tracking of required regulatory documents to populate the electronic Trial Master File (TMF) for designated studies. Generate reports of missing documents and upcoming expiration dates. Communicate with sites and/or study team to obtain required documents. Ensure the TMF is audit-ready in support of regulatory filings.
• Obtain safety-related source documents and images from clinical sites in preparation for Clinical Event Committee and Data Safety Monitoring Board meeting packages. Work with translation vendors as needed.
• Track device inventory and prepare shipments to sites, ensuring device integrity is maintained (i.e., temperature control and expiration dates). Process returned/expired devices.
• Assist with the distribution and tracking of clinical study supplies to Contract Research Organizations (CROs) and clinical centers (e.g. study binders, case report form worksheets, study devices and misc. materials)
• 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

Education And/or Experience

• Undergraduate degree
• 2-3 years of relevant clinical trial experience

Required Knowledge/Skills

• Minimum of 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

Desired Knowledge/Skills

• Minimum of 1-2 years of Sponsor or CRO experience
• Working knowledge of CDISC TMF Reference Model

Physical Demands/Working Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to sit or stand for prolonged periods of time, frequently in front of a computer.

Salary: $28.00 - $34.00 per hour