Clinical Research Associate / Clinical Project Manager

Founded in 2020 and based in Silicon Valley, Empo Health is a seed-funded, VC-backed, and NSF-supported startup developing revolutionary in-home health monitoring products. We’re looking for an experienced clinical research associate or clinical project manager to join our team and oversee Empo Health’s pilot studies with Mount Sinai Health System, 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 associate or clinical project manager working with Mount Sinai, you will be responsible for generating documentation for study startup, monitoring studies, gathering study data, and digitizing that data.

This is a hands-on role – as Empo’s first full-time “boots on the ground” with Mount Sinai, you will help ensure that Empo’s pilot studies run successfully. You will work with other teams at Empo Health as well as collaborate with Mount Sinai’s clinical and research staff. Your work will directly contribute to eliminating the diabetic foot ulcers that impact millions of at-risk patients, 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!

This role is a full time position. Work will involve routine travel to/within/near New York City as needed, especially to Mount Sinai’s Center for Advanced Medicine. Job responsibilities include:

• Prepare clinical study documents and other materials (e.g. study binders) for Empo Health’s pilot studies with Mount Sinai

• Assist with IRB submissions and communications

• Monitor pilot studies, ensuring adherence to the clinical protocol, applicable regulations, data integrity, and accurate reporting

• Propose and implement improvements to study operations

• Generate study reports

• Set up clinical study databases

• Collect study data documents and digitize files

• Track adherence to study schedules

• Collaborate with Empo Health personnel as well as Mount Sinai clinical and research staff

• 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

• Have training and working experience with Good Clinical Practice (GCP)

• 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 approvals phase, through the study startup 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 excellent English verbal and written communication skills

• Are passionate about improving access to high quality healthcare

• Have conducted studies for both FDA Class I and Class II medical products, or Significant Risk (SR) and Non-Significant Risk (NSR) studies

• 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/submissions

• Are well-versed in diabetic neuropathy and foot ulcers

• Are familiar with biostatistics platforms and have experience managing and organizing large data

• Are able to perform rudimentary data analysis

• Are fluent in Spanish

• Hybrid-friendly working environment

• “Take what you need” vacation and sick leave policy as long as you are able to accomplish the duties of your role

• Generous coverage for medical, dental, and vision plans

• 12 week parental leave + part-time transition period at full pay

• Equity incentive options for early full-time employees

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.