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REVA Medical, LLC. · 4 days ago

Contract Clinical Research Assistant (3 to 6 months)

San Diego, CA

Full-time, Contract

Onsite

Entry, Mid Level

$25/hr - $30/hr

2+ years exp

REVA Medical, LLC. is seeking a Contract Clinical Research Assistant to provide departmental administrative support in Clinical Affairs. The role involves managing regulatory documents, ensuring audit readiness, and assisting with clinical study supplies and invoicing.

BiotechnologyHealth CareMedicalWellness

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

Track and ensure study-related images are obtained from sites and provided to Core Labs for analysis in a timely manner

Assist in providing feedback to sites as needed

Obtain safety-related source documents 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

Assist in processing and tracking of study related costs

Provide general administrative support as needed