Senior Clinical Research Associate

Luminate Medical • Nashville, TN

4d • Hybrid

About The Position

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 Senior Clinical Research Associate to play a key role in supporting the execution of pivotal clinical trials. Working closely with our Director of Clinical Operations, you will be the main point of contact in ensuring clinical trial execution at the sites is operating in accordance with GCP and study timelines. This is a key hire within the Clinical Operations Department, at a rapidly growing startup. You will have an opportunity to manage components of start-up, execution, and close-out of key pivotal clinical trials. You’ll be hands-on with the devices and with managing clinical sites as a representative of the sponsor company. Closely collaborate with a team that trusts your judgment and empowers you to act. Be part of a company that’s scaling up, offering ample opportunity to step up as trials and device portfolio continue to expand.

Requirements

• Bachelor’s degree in Life Sciences or a related field.
• 3–5+ years of hands-on experience within the medical device and/or pharmaceutical industry
• Prior experience with Trial Master File (TMF) management
• Prior experience and proficiency in utilizing Electronic Data Capture (EDC) systems
• Deep understanding of GCP, ISO 14155, and FDA regulations for medical devices
• Willingness and ability to travel 30-40% during active clinical trials period

Nice To Haves

• Master’s degree preferred.
• Experience within biotech start-ups
• Experience working for a Sponsor company
• Experience in the Oncology therapeutic area.
• Strong site relationship management skills
• A passion for working in small, entrepreneurial environments where everyone wears multiple hats.

Responsibilities

• Act as the subject matter expert for Luminate Medical devices, serving as the primary point of contact between sponsor and site staff.
• Manage and maintain essential study documents in compliance with sponsor requirements, study-specific processes, and Luminate SOPs.
• Collaborate with internal and external clinical teams to support all phases of clinical trials, including study start-up, site initiation visits (SIVs), trial execution, and close-out.
• Perform weekly check-ins with clinical sites to track progress, address issues, and provide ongoing support.
• Contribute to departmental projects and initiatives, ensuring timely and high-quality deliverables.
• Proactively identify and escalate training needs, project updates, quality concerns, and timeline risks to the clinical team.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior