Clinical Trial Assistant (Part-time)
About The Position
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.
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
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What This Job Offers
Job Type
Part-time
Career Level
Entry Level
