Clinical Trial Assistant (Part-time)

Part-Time Clinical Trial Assistant (CTA)

At Lumicell, we'll give you the opportunity to harness all that's within you by working in a mission-driven start-up environment with high-performing employees, tackling some of the most important challenges in cancer surgery. We are working to revolutionize the way cancer surgery is performed today, starting with breast cancer. Women in the US have a 1 in 8 lifetime risk of being diagnosed with breast cancer. You will be a part of something groundbreaking as we expand our commercial launch and continue investigations in other cancer indications.

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.

What you will do:

Clinical Team Administration & Coordination

• 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.
• Clinical Systems & Study Support
• 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 you will bring:

• Bachelor's degree or equivalent experience
• 13+ 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

Position Type/Expected Hours of Work:

This is a part-time contract position, 20-25 hours per week.

Lumicell is committed to a diverse and inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values.

Lumicell is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Lumicell will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.