Senior Clinical Research Associate

Clinical & Medical Affairs      ·       United States       ·       Full time

Who We Are

Tesseract’s mission is to democratize healthcare delivery to everyone on a global scale. We are reinventing medical devices to leverage the health information in the human eye and championing a new era of healthcare by creating portable, affordable, easy to use, connected devices for early disease detection and monitoring. Tesseract is well-funded and recently raised a series B round of $80M.

We are part of 4Catalyzer – a rapidly growing health-tech incubator founded by Dr. Jonathan Rothberg, an award-winning scientist and highly successful serial entrepreneur. Our 4Catalyzer sister companies include Butterfly Network, the first whole-body Ultrasound-on-ChipTM, and Hyperfine, the first FDA-cleared portable MRI. We are fostering a culture of technical excellence and positive teamwork to solve real-world problems that help improve healthcare for billions of people around the world.

Joining Tesseract is the opportunity to redesign the future of healthcare through the power of technology. Join us on this journey to maximize global impact, motivated by the idea that our products will change lives, including the ones of people you love.

What We Live By

• Patients First: We are driven to make products that will improve people’s lives.
• Data-Driven: We search for the best solutions: objective, backed by data, and optimized for speed, simplicity and scale.
• Team-Oriented: We collaborate with and support each other every step of the way.

What You Will Be Doing

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 and reporting to the Director of Clinical Operations, your core responsibilities will be: 

• Work with the Director of Clinical Operations to design, plan, conduct, and monitor clinical studies. 
• Develop clinical studies protocols, technical documentation including informed consents, case report forms, study tools, and study training documents.
• Execute FDA, research and post-market clinical studies in line with institutional, GCP, regulatory, and compliance requirements.
• Work with key opinion leaders and medical advisors in ophthalmology.  Maintain working relationships with clinical sites, investigators, and clinical study coordinators.
• Assist 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
• Assist in the preparation and submission of clinical protocols, FDA clearance and other documents (e.g., IRB/ethics committees, QMS)
• Maintain source documents and subject files in accordance with clinical testing policies and procedures. Ensure 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.  Maintain good notes on perceived optimizations, opportunities, features, form factor adjustments.

What We Are Looking For

Baseline Skills, Experiences, & Attributes:

• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing, medical or laboratory technology. Advanced degree is a plus. OD preferred but not required.
• 5+ years of technical, hands-on clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) at a pharmaceutical, biotech or medical device company. Additional experience at a CRO is a plus. 
• Knowledge of ophthalmology is preferred but not required.
• 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.
• Thorough knowledge and understanding of FDA and/or EMA regulations (or relevant local regulations), ICH Guidelines and GCPs governing the conduct of clinical trials.
• 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 and changing environment
• Ability and willingness to travel up to 50%-70% of the time

What We Offer

• Fully covered medical insurance plan, and dental & vision coverage (as a health-tech company, we place great worth on our team’s well-being)
• Competitive salaried compensation (you should feel appropriately valued and excited to join us)
• Equity (employees are important and should have a stake in our success)
• Pre-tax commuter benefits (let’s make your commute costs more reasonable) 
• Free onsite meals + kitchen stocked with snacks at our Guilford, CT campus (sponsored brain fuel)
• While we would love to see you face to face everyday, we are flexible and open to people being remote. We will always have opportunities to meet your coworkers off the screen at one of our many team outings. (no pressure though)
• 401k plan (everyone should be encouraged to save for their retirement adventures)
• 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 E-Verify and 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.

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