Clinical Research Specialist

South San Francisco, CA /
Clinical Studies /
Full-time (Hybrid-Friendly)
Founded in 2020 by MIT and Stanford Engineers and based in Silicon Valley, Empo Health is a seed-funded and NSF-supported startup developing revolutionary in-home health monitoring products.

We’re looking for an experienced clinical research specialist to join our team and take charge of research and pilot studies at Empo Health, playing a critical role in demonstrating clinical and commercial viability of our suite of in-home health monitoring products.

Empo Health’s first product is a foot-scanning system that helps doctors and patients monitor for early signs of diabetic foot ulcers, and the team is hard at work preparing the world-class device and associated digital health platform for launch. To bring this product to market, Empo will conduct a series of pilot and research studies of increasing rigor. As the clinical research specialist, you will be responsible for assisting with study planning, starting up and executing studies, gathering clinical data, and performing data analysis.

This is a hands-on role – as our first research specialist, you will help shape Empo Health’s research strategy. You will be responsible for protocol drafting, budgeting, facilitating IRB approval with institutional leaders, collecting data, debriefing, analyzing data, and assisting in manuscript publication. You will work with other teams at Empo Health as well as collaborate with Empo’s partner institutions, balancing constraints from every stakeholder to ensure studies are as impactful as possible. Your work will directly contribute to eliminating the diabetic foot ulcers that impact millions of at-risk patients, potentially preventing amputations and saving lives.

In this role you will work closely with the founders and other early team members, and should be comfortable being a critical member of a small team. You should be comfortable breaking high-level directives into tangible tasks, setting your own direction and adapting to changes.

If you’re passionate about creating seamless health monitoring devices that have the opportunity to expand access to high quality healthcare, and you want to work with an interdisciplinary team to build that future, then we’d love to hear from you!

The job

    • Plan studies alongside founders and early team members to validate Empo Health’s system, ensuring that considerations for product development, business goals, and research best practices are all key drivers
    • Determine effective strategies for enrolling research participants, and oversee study enrollment Develop and manage systems to organize, collect, report, and monitor data collection during studies; perform statistical analysis of findings
    • Develop project schedules, targets, measurements, and accountabilities
    • Draft protocols and facilitate institutional IRB approvals, monitoring IRB submissions to respond to requests and questions
    • Collaborate with Empo’s partner institutions and resolve study queries
    • Develop study budget with early team members, and track expenditures versus budget
    • Ensure regulatory compliance as applicable, including FDA, HIPAA, and GCP
    • Write up research findings and assist in publication processes

You might be a good fit if you

    • Have industry experience with investigator initiated studies (IIS), real world evidence (RWE), and randomized control trial (RCT) studies for patient-facing medical devices and digital health technologies, including questionnaire design and advanced statistical analysis
    • Have direct experience with communication practices using confidential information (HIPPA and GCP)  with clinical sites
    • Are willing to travel to clinical sites as necessary, and abide by all COVID-19 safety measures enforced by all involved institutions
    • Have experience with studies from beginning to end, from the planning and budgeting phase, through the execution phase, and into the analysis and write-up phase
    • Grasp medical terminology well enough to build your medical knowledge of diabetic neuropathy and foot ulcers
    • Have an advanced scientific degree or equivalent industry experience in a relevant field
    • Have excellent English verbal and written communication skills
    • Are passionate about improving access to high quality healthcare

Even better if you

    • Have conducted studies for both FDA Class I and Class II medical products
    • Have conducted studies for devices used in patient homes
    • Have conducted studies for remote patient monitoring technologies
    • Have worked with a medical device startup
    • Have experience working with data pulled from Electronic Health Record systems (especially Epic)Have a successful track record of research proposals
    • Are well-versed in diabetic neuropathy and foot ulcers
    • Are familiar with biostatistics platforms and have experience managing and organizing large data

What we offer

    • Hybrid-friendly working environment
    • “Take what you need” vacation and sick leave policy
    • Generous coverage for medical, dental, vision, and mental wellness plans12 week parental leave + part-time transition period at full pay
    • Equity incentive options for early full-time employees
Important Note

Promoting diversity of backgrounds is extremely important at Empo Health. Although we do our best to list everything we are looking for in a candidate, we may be missing skills and/or attributes that could make you a great fit for the role. If you think you might fit this role but don’t perfectly match the description above, then please still apply! We would hate for both of us to miss out on a great opportunity.