Clinical Trial Assistant (Part-time)

Lumicell • Waltham, MA

6d

About The Position

The Part-Time Clinical Trial Assistant (CTA) provides administrative and operational support to Lumicell’s Clinical Affairs organization. This role supports regulated clinical documentation, clinical systems administration, and cross-functional coordination across Clinical Affairs, Clinical Operations, Regulatory Affairs, Quality Assurance and Medical Affairs. We are looking for a self-starting and collaborative team member to support multiple aspects of a post-market and investigational drug/device combination product.

Requirements

• Bachelor’s degree or equivalent experience
• 1–3+ years experience as a Clinical Trial Assistant or similar role
• Experience with CTMS and eTMF systems
• Familiarity with GCP, CFR, ICH and clinical operations best practices
• Strong attention to detail and organizational skills

Responsibilities

• Prepare, distribute, and archive Clinical Team meeting agendas and minutes
• Maintain and manage a Clinical Team action item tracker
• Provide operational support across Clinical Affairs, Regulatory Affairs, and Medical Affairs
• Support site engagement communications, including study start-up and follow-up support
• Update and maintain Lumicell documents including Clinical Affairs SOPs, study procedures, templates, work instructions, etc.
• Perform Clinical Trial Management Software (CTMS) administrative tasks including study maintenance and data quality checks
• Perform electronic Trial Master File (eTMF) administrative activities including filing, QC, and readiness support
• Ensure documentation compliance with internal procedures and regulations
• Maintains structure and organization for shared inboxes
• Support data reconciliation activities

What This Job Offers

• Job Type: Part-time
• Career Level: Entry Level