Job Opportunities API

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,  a t 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 a n   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  r egulations .  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 with in 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- 4 0% during active clinical trials period Advantages – It Would be Advantageous to Have: • E xperience  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!