Temporary Part-Time Clinical Research Associate

at  identifeye HEALTH Inc

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.

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 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