Temporary Part-Time Clinical Research Associate

Who We Are

Join us on our mission to democratize access to the abundance of health information in the human eye! Here at identifeye HEALTH Inc., we’re pioneering a new branch in diagnostics between laboratory medicine and radiology, that will enable regular non-invasive health monitoring for both ocular and systemic diseases. 

We believe in empowering the individual by building approachable and intuitive products to provide personalized health insights to each and every patient. Our products are portable, affordable, easy to use and connected devices for early disease detection and monitoring.

We are born from 4Catalyzer - a rapidly growing health-tech incubator founded by Dr. Jonathan Rothberg, an award-winning scientist and highly successful serial entrepreneur. We are fostering a culture of technical excellence where you have the opportunity to learn, explore and see your ideas come to life. 

Joining identifeye HEALTH is the opportunity to redesign the future of healthcare through the power of technology. We are here to solve real-world problems and maximize global impact, motivated by the idea that our products will change lives, including the ones of people you love.

What We Live By

• Prioritize the Patient - We make products that remove barriers between quality care and the people who need it 
• Data-Driven Decisions - We search for the best solutions; objective, backed by data, and optimized for speed, simplicity and scale
• Support Each Other - We celebrate the ideas and contributions of our teammates and recognize that we can only succeed as a team, and when each person feels heard and valued
• Simplify - We build intuitive solutions to simplify patient care

What You Will Be Doing

Please note that this is a temporary position

• Estimated Start Date: ASAP
• Estimated Duration: 6-7 months
• Schedule: Part-time - 20 hours per week
• Work Location: Remote with a strong preference for candidates based in Texas or on the west coast
• Travel Requirements: Ability and willingness to travel up to 50%-70% of the time (typically within an assigned region)

The identifeye HEALTH Clinical Research Associate (CRA) is a role that combines the traditional CRA field monitoring responsibilities with in-house trial maintenance responsibilities. The individual(s) fulfilling this role will be responsible for varied aspects of trial and site oversight and management. The CRA(s) will serve as a primary point of contact for clinical sites, from study start-up through enrollment/conduct and close-out. CRA(s) will conduct regular in-person initiation, monitoring, and close-out site visits and be available to site staff remotely to answer questions and help resolve study-related issues. Additional potential tasks will include developing and maintaining investigator and site relationships, monitoring clinical research sites, and contributing to the development and maintenance of trials documents and eTMFs. Clinical Research activities include (but are not limited to) the evaluation of investigational ophthalmic imaging devices.  

As part of our cross-functional team, your core responsibilities will entail the following: 

• Participate in clinical site identification, selection, on-boarding/activation, management, monitoring and close-out  
• Serve as the primary point of contact between the sponsor and the assigned clinical sites. Maintain regular communication as well as a physical, in-person presence at assigned clinical sites, developing and maintaining positive relationships with site staff.  
• Train extensively on identifeye HEALTH and our CRO partner’s systems and processes
• Train extensively on both investigational and FDA-cleared medical devices to enable effective  implementation of device user training and to provide first-responder troubleshooting to sites in case of device issues
• Schedule site visits, discuss enrollment statistics and challenges with site staff, place and resolve data queries, respond to (and appropriately escalate within iDH) issues with study systems and devices, ensure sites collect data per protocol, and that sites routinely enter data into EDC in a manner compliant with both the relative protocol and the clinical trial agreement
• Assist in the collection, preparation, and eTMF filing of documents required for site activation (“greenlight”) and maintenance 
• Ensure PI and site staff develop, use, and maintain source documents and subject files in accordanc