Shape the Future of Cancer Treatment at Luminate

Luminate is on a mission to change the way we experience cancer care. We design and build products which revolutionize the patient experience of cancer treatment by eliminating the financial, physical, and temporal side effects of anti-cancer therapy. Our development programs include enabling at-home lab draws and infusions, preventing peripheral neuropathy, and preventing hair loss caused by chemotherapy. We’ve proven our ability to bring technologies to patients, with several active clinical trials around the world.

We’re looking for a Document Control/TMF Specialist to
play a key role in supporting the execution of pivotal clinical trials by managing essential study documentation. Working closely with our Sr. Clinical Research Associate and Director of Clinical Operations, you will be the main point of contact in ensuring clinical trial documentation is up to date and compliant with GCP.

Working at Luminate

• This is an important hire within the Clinical Operations Department, at a rapidly growing startup. You will have an opportunity to contribute to the start-up, execution, and close-out of key pivotal clinical trials.

What You Will Do:

• Manage and maintain study documents in alignment with sponsor requirements, study-specific processes, and Luminate SOPs.
• Collaborate closely with clinical study teams to support documentation needs and ensure timely completion of TMF activities.
• Perform document processing tasks including receipt, review, scanning, indexing, quality control, filing, and archiving.
• Support departmental projects and initiatives, ensuring timely and accurate completion.
• Provide updates and data for departmental status reports as needed.
• Escalate training needs, project updates, quality concerns, and timeline risks to the clinical team

Personal Attributes – The Ideal Candidate Is:

• Communicative: Proficient in written and verbal communication and collaboration skills. You are able to identify appropriate communication channels for problems and concerns.
  
  

• Self-Driven: You have a sense of urgency in your work and thrive when taking responsibility for tasks. Proactive thinker and problem-solver with an enthusiasm to learn new concepts and a growth mindset.

• Attention to Detail: Understands and adheres to company policies and procedures. Understands and adheres to all external standards, and applicable regulations. Ability to work under strict guidelines, competing priorities, and immediate requests.

• Professional: Displays a neat, clean, and professional appearance at all times.
  

Requirements – The Ideal Candidate Must Have:

• Bachelor’s degree in Life Sciences or a related field.
• 1–3 years of hands-on experience with Trial Master File (TMF) management in a clinical research setting.
• Strong understanding of good clinical practice (GCP), clinical study documentation, and regulatory requirements.

Advantages – It Would be Advantageous to Have:

• Prior experience within the medical device industry and start-ups
• Proficiency in utilizing Electronic Data Capture (EDC) systems
• Ability to learn and become competent with company used computer, telephone, and EDCs, where applicable

Don’t have all of these requirements?

Some people are less likely to apply for a role unless they are 100% qualified. Your experience, skills and passion will set you apart - tell us what you have learned and achieved, whether personal or work-related! With the right mindset, many of the skills above can be learned on the job. If this role excites you, don’t let the description hold you back!