In-House Clinical Monitor

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 an In-House Clinical Monitor to play a key role in ensuring the quality, compliance, and successful execution of our clinical trials. Working closely with our Director of Clinical Operations, you will independently conduct monitoring visits across Luminate's clinical sites, perform detailed source data review and verification, document and communicate findings, and ensure sites are operating in accordance with study protocols, GCP, and applicable regulatory requirements.

This is a hands-on, sponsor-side monitoring role for someone who is comfortable getting into the details of source records, identifying potential gaps or inconsistencies, and working directly with sites to drive findings through resolution.

• This is a key hire within the Clinical Operations Department at a rapidly growing startup. You will have direct responsibility for monitoring activities across key pivotal and early-stage clinical trials. You'll be hands‑on with our devices and work directly with clinical sites as a representative of the Sponsor.
• You’ll be responsible to monitor studies requiring 100% Source Data Verification (SDV).
• You’ll work closely with Clinical Operations, Data Management, Quality, and other internal teams to ensure high-quality, reliable clinical data.
• You’ll collaborate with a team that trusts your judgment and empowers you to identify issues, elevate concerns, and drive them through resolution.
• You’ll be part of a company that is scaling rapidly, offering opportunities to take on greater responsibility as our clinical programs and device portfolio expand.

• Perform comprehensive Source Data Review (SDR) and Source Data Verification (SDV), including 100% SDV where required by the study Monitoring Plan.
• Review source documentation to identify potentially missing or under reported adverse events, protocol deviations, treatment interruptions, device deficiencies, or other clinically relevant study information.
• Review investigational device accountability, including device receipt, assignment, use, replacement, storage, return, and disposition.
• Prepare clear, comprehensive, and timely Monitoring Visit Reports and site follow-up letters, documenting findings, required actions, and resolution timelines.
• Track monitoring findings and action items through documented resolution and ensure previously identified findings are appropriately addressed during subsequent monitoring activities.
• Proactively identify and elevate significant or recurring compliance concerns, data quality issues, protocol deviations, training needs, and risks to participant safety or study integrity.
• Work directly with site investigators and research staff to resolve monitoring findings and provide targeted retraining where needed.
• Collaborate closely with Clinical Data Management to resolve data discrepancies and outstanding queries and support data cleaning activities.
• Support targeted monitoring and data review activities in preparation for interim analyses, database locks, audits, and regulatory inspections.
• Act as a knowledgeable representative of Luminate Medical and develop a strong understanding of Luminate devices,…