Clinical Research Associate

  • New York, NY, USA
  • Full-time

Company Description

Imagine a world in which cost and training are no longer barriers for access to life saving technology. A world in which medical devices become smarter with each new patient they see. At 4Catalyzer we are making that vision a reality. We operate at the intersections of medicine, engineering, and machine learning with a collective goal to change the world and save the life of someone you love. If you are not satisfied with the status quo, have a passion for making a difference in the world, and love fast-paced innovative environments, we want you.

The eye is the window into the human body. At Tesseract, we are harnessing the informational power of the retina to diagnose pathologies and save lives through early intervention. We are building a handheld, user-friendly device that will give patients and doctors access to their general health data. We are seeking brilliant, gritty, passionate people who want to illuminate the hidden information of the body and democratize healthcare. In this early stage, you can have a significant stake in the company and ownership over your work. As a 4Catalyzer company, home of unicorn Butterfly Network, we benefit from being part of an incubator with 300 scientists and engineers and over $600 Million in funding.

Job Description

The Clinical Research Coordinator is a research position, responsible for conducting and assisting in clinical research studies, obtaining informed consent, collecting, maintaining and organizing study information. Research activities involve (but are not limited to) the evaluation of prototype, or newly-released ophthalmological scanning devices.  This individual assists in the preparation and submission of FDA clearance and other documents (e.g., Institutional Review Board, Quality Management Systems)

  • Identifies and works with key opinion leaders and medical advisors in ophthalmology.  Conducts routine and standardized human subjects research using appropriate research techniques specific to subject matter of the research project.
  • Assists in the activities related to clinical research including, but not limited to: obtaining informed consent, screening participants for eligibility, registering patients with sponsoring agencies, administering questionnaires and answering telephone calls
  • Assists in the collection, analysis and review of experimental data.
  • Maintains source documents and subject files in accordance with clinical testing policies and procedures. Ensures accurate, confidential and complete compilation of data
  • Work with legal, research, and logistics personnel to develop research agreements that define the required equipment, funding and deliverables for research projects.  Track budget, milestones, and deliverables throughout the project.
  • May assist in the preparation for regulatory agency site visits.
  • May collect and communicate user and patient experiences with the devices and the interfaces.  Maintains good notes on perceived optimizations, opportunities, features, form factor adjustments.

Qualifications

  • MS or PhD in Engineering or an MD. (PhD or MD preferred)
  • 3-5 years of technical, hands-on clinical management experience at a top technology or medical device company. Prior experience with ophthalmology desired.
  • Prior experience with commercial medical product clinical research, the creation and execution of clinical projects, FDA validation, and understanding of clinical workflow towards product incorporation.
  • Proficient in interpersonal communication skills, written and verbal for both internal and external entities.  Must be able to work in a team environment.
  • Demonstrated ability to understand, evaluate and interpret data

Additional Information

All your information will be kept confidential according to EEO guidelines.