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 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. Working at Luminate
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
What You Will Do:
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.
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. Master's degree preferred.
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
Advantages - It Would be Advantageous to Have:
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.
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!