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: 9 months
• Schedule: Part-time - 20 hours per week
• Work Location: Remote with a strong preference for candidates based in Texas and Southern U.S. 
• 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 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 accordance with clinical testing policies and procedures. Ensure accurate, confidential, and complete compilation of data.

Additional (possible) responsibilities:

• Assist in the development of necessary monitoring documentation and materials including but not limited to: SOPs, monitoring plans, informed consent forms, case report forms, visit report and letter templates, and site training materials including slide decks (investigator meeting, site qualification, site initiation, etc.), and site reference materials/tools
• File study documents within the studies’ eTMF as necessary
• Assist in maintaining regulatory document trackers and process trackers (e.g., site status tracker, site enrollment tracker) through the duration of the trial(s)
• Review study data (including study images) to ensure quality, protocol and procedure compliance, and that study participant privacy and confidentiality are maintained throughout the trial
• Review and trend data towards ensuring sites are meeting enrollment goals and data quality expectations
• Assist sites in instances of regulatory agency site visits
• Collect and communicate to iDH team device operators and study participant experiences with the devices and the interfaces.  Maintain good notes on perceived optimizations, opportunities, features, and form factor adjustments.

What We Are Looking For

Baseline Skills, Experiences, & Attributes:

• Degree: University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, in nursing, medical or laboratory technology.  
• Prior ophthalmology clinical trial experience is desirable but not mandatory
• 1+ 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 sponsor company and/or a CRO company
• Knowledge and understanding of FDA regulations, ICH Guidelines and GCPs governing the conduct of clinical trials.
• Highly proficient in interpersonal communication skills, written and verbal, for both internal and external entities  
• Must be able to work both independently and within a cross-functional team environment. Ability to interact professionally with all organizational levels.
• Demonstrated attention to detail, ability to be proactive and appropriately reactive, and ability to understand and evaluate data quality
• Ability to manage competing priorities in a fast paced and changing environment
• Ability and willingness to travel up to 50%-70% of the time (typically within an assigned region)

What We Offer

identifeye HEALTH Inc. does not accept agency resumes.

identifeye HEALTH Inc. 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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