Clinical Research Assistant

Reva Medical LLC•San Diego, CA

2d•$28 - $34•Onsite

About The Position

The primary function in this position will be to provide departmental administrative support in the area of Clinical Affairs. This includes performing quality checks, uploads, and tracking of required regulatory documents to populate the electronic Trial Master File (TMF) for designated studies. The role involves generating reports of missing documents and upcoming expiration dates, communicating with sites and/or study teams to obtain required documents, and ensuring the TMF is audit-ready in support of regulatory filings. Additionally, the position requires obtaining safety-related source documents and images from clinical sites for meeting packages, working with translation vendors, tracking device inventory, preparing shipments to sites, and processing returned/expired devices. The role also involves assisting with the distribution and tracking of clinical study supplies, interfacing with CROs, assisting with site invoicing and payment tracking, organizing and filing study-related materials, and aiding in the organization and execution of Investigator meetings. General administrative support will also be provided as needed.

Requirements

Undergraduate degree
2-3 years of relevant clinical trial experience
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

Nice To Haves

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

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.