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Democratizing Medicine

Senior Clinical Research Associate

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Company Description

Tesseract’s mission is to democratize healthcare delivery to everyone around the world. We are reinventing medical devices and championing a new era of healthcare by creating a portable, affordable device for monitoring and preventing disease. This breakthrough optic technology reinforces that the eye is a window into the human body.

Tesseract is a well-funded, rapidly growing health-tech incubator founded by award-winning scientist and highly successful serial entrepreneur, Dr. Jonathan Rothberg. Tesseract benefits from being a 4Catalyzer company, an incubator of health-tech companies (most notably Butterfly Network) who has raised over $700 million in funding.

Joining Tesseract is the opportunity to redesign the future of healthcare through the power of technology. Embark on a journey with us to maximize global impact, motivated by the idea that our products will change the lives of millions along with the people you love.

Job Description

The Senior Clinical Research Associate is a research position, responsible for conducting and monitoring clinical research studies. Clinical Research activities involve (but are not limited to) the evaluation of prototypes, or newly-released ophthalmological scanning devices.

As part of our team, your core responsibilities will be:

  • Designs, plans, conducts, and monitors clinical studies.
  • Develop clinical studies protocols, technical documentation including informed consents, case report forms, study tools, and study training documents.
  • Lead FDA, research and post-market clinical studies in line with institutional, GCP, regulatory, and compliance requirements.
  • Identifies and works with key opinion leaders and medical advisors in ophthalmology. Maintains working relationships with clinical sites, investigators, and clinical study coordinators.
  • Assists in the activities related to clinical research including, but not limited to: training of investigators and clinical site personnel, assisting investigators in screening participants for eligibility, collection reporting and review of data
  • Assists in the preparation and submission of clinical protocols, FDA clearance and other documents (e.g., IRB/ethics committees, QMS)
  • 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 management to develop research agreements that define the scope and deliverables for research projects. Track budget, milestones, and deliverables throughout the project.
  • Assist in the preparation for regulatory agency site visits.
  • 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

Baseline skills/experiences/attributes:

  • Degree in a relevant scientific discipline. OD preferred
  • 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
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast paced environment

You Deeply Identify with Core Tesseract Values:

  • Efficient & Speedy - you get work done in a fraction of the time as industry peers
  • Intellectually Curious - you are thoughtful & inquisitive; people enjoy working with you because they learn from you
  • Mission-Driven & Committed - you are passionate about the company's purpose and are immensely productive
  • Team Oriented - you celebrate and take joy in the success of others on the team

Additional Information

We offer great perks:

  • Fully covered medical insurance plan, and dental & vision coverage - as a health-tech company, we place great worth on our teams’ well-being
  • Competitive salaried compensation - we value our employees and show it
  • Equity - we want every employee to be a stakeholder
  • Pre-tax commuter benefits - we make your commute more reasonable
  • Free onsite meals + kitchen stocked with snacks.
  • 401k plan - we facilitate your retirement goals
  • Beautiful office overlooking the Flatiron building in NYC OR Beautiful office near the ocean-front in historic Guilford, Connecticut
  • The opportunity to build a revolutionary healthcare product and save millions of lives!

For this role, we provide visa assistance for qualified candidates.

Tesseract does not accept agency resumes.

Tesseract is an equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.

4Catalyzer at a glance

Democratizing Medicine

4Catalyzer focuses on Biotechnology, Medical Devices, Cloud Computing, and Deep Learning. Their company has offices in New York City. They have a mid-size team that's between 51-200 employees.

You can view their website at http://www.4catalyzer.com or find them on Twitter, Facebook, and LinkedIn.

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