Tech Stack

Description

You will support the day-to-day operations of a Phase 3 clinical trial, including start-up, conduct, and close-out activities. You'll track regulatory documents, manage spreadsheets, coordinate with CROs and vendors, and assist with contracts and finance activities.

Requirements

• B.A./B.S. degree required
• At least 2 years of work experience supporting clinical trials
• Proficient with TMF and Veeva Vault
• Proficient computer skills with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
• Ability to prioritize and manage competing priorities
• Team oriented and able to collaborate with study team and external partners
• Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements

Responsibilities

• Collect, track and conduct initial review of site regulatory documents for IP release and TMF filing
• Maintain tracking spreadsheets for subject tracking, essential documents, samples, and investigational product tracking
• Track and coordinate CRO and third-party vendor activities, including meeting minutes and study updates
• Assist with tracking clinical trial progress, IP, clinical lab samples, and central reader/lab data
• Facilitate review and execution of CDAs, contracts, and work orders through legal approval process
• Perform first pass review of site and vendor invoices and generate monthly/quarterly accruals
• Communicate directly with sites, CROs, and field CRAs to obtain updates and essential documents
• Assist with organization and conduct of internal team meetings, investigator meetings, and other trial-specific meetings
• Receive and review regulatory documents from sites for accuracy and compliance
• Assist with development of site tools, clinical trial start-up activities, and study materials
• Organize, maintain, and participate in audits and close-out of Trial Master File (TMF/eTMF)
• Participate in EDC specification and user acceptance testing processes