We9re 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 Luminate9s 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.
Working at Luminate
- 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. You9ll be hands-on with our devices and work directly with clinical sites as a representative of the Sponsor.
- You9ll be responsible to monitor studies requiring 100% Source Data Verification (SDV).
- You9ll work closely with Clinical Operations, Data Management, Quality, and other internal teams to ensure high-quality, reliable clinical data.
- You9ll collaborate with a team that trusts your judgment and empowers you to identify issues, escalate concerns, and drive them through resolution.
- You9ll be part of a company that is scaling rapidly, offering opportunities to take on greater responsibility as our clinical programs and device portfolio expand.
What You Will Do
- 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 underreported 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 escalate 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, clinical protocols, and study procedures.
- Contribute to the development and continuous improvement of monitoring tools, templates, processes, and SOPs as Luminate9s clinical portfolio grows.
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
- Bachelor9s degree in Life Sciences, Nursing, Health Sciences, or a related field.
- Minimum 3-5 years of direct, hands-on clinical monitoring experience within the medical device, biotechnology, and/or pharmaceutical industry.
- Demonstrated experience independently conducting on-site clinical monitoring visits, including IMVs.
- Demonstrated experience performing comprehensive Source Data Review and Source Data Verification, including experience with 100% SDV.
- Prior experience independently preparing high-quality Monitoring Visit Reports and site follow-up letters.
- Experience with investigational product and/or medical device accountability.
- Proficiency with Electronic Data Capture (EDC) systems and clinical data review.
- Strong understanding of GCP and applicable FDA clinical research regulations.
- Strong written communication and documentation skills.
- Ability to independently prioritize and manage multiple sites and monitoring activities.
- Willingness and ability to travel approximately up to 50% during active clinical trial periods, based on study needs.
Advantages - It Would Be Advantageous to Have
- Medical device clinical trial monitoring experience.
- Experience in the Oncology therapeutic area.
- Experience supporting interim analyses and database-lock readiness.
- Experience working directly for a Sponsor company.
- Experience within startups.
- Strong site relationship management skills.
- A passion for working in small, entrepreneurial environments where everyone wears multiple hats.
Don9t 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, don9t let the description hold you back!
