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Part-Time Clinical Operations Contractor

United States

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 contract position

Estimated Start Date: ASAP

Estimated Duration: 1 year+

Estimated Hours: Around 20 hours per week

The Contract Clinical Operations role will provide support for the execution of all FDA, research and post-market clinical studies of the company’s ophthalmic imaging devices. The ideal candidate will bring strategic thinking and operational excellence, and will work closely with other team members, affiliates and CROs to proactively identify, resolve and escalate issues that may jeopardize project completion on time or within budget.  

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

  • Support execution of all operational aspects of clinical studies, including tracking budget, milestones, and deliverables for each study
  • Contribute to the quality of clinical programs and deliverables and ensure all study activities are completed in accordance with ICH GCP, health authority regulations and SOPs
  • Assist with participant recruitment strategies, operational feasibility and implementation path of the study/program objectives
  • Assist in the activities related to clinical studies including, but not limited to: development of departmental SOPs, site identification, 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 study protocols and technical documentation including informed consents, case report forms, study tools, and study training documents
  • Maintain source documents and subject files in accordance with clinical testing policies and procedures. Ensure accurate, confidential and complete compilation of data.
  • Maintain working relationships with clinical sites, investigators, and clinical study coordinators
  • Support the team through inspection readiness activities and address any audit findings appropriately and promptly
  • Support the team through identification and mitigation of risks to study implementation, enrollment, conduct and compliance
  • Identify and provide solutions and direction related to key cross-functional, site, and CRO clinical study issues
  • Support the development and review of training and educational materials to ensure accurate and effective product messaging
  • Support the development and review of clinical and scientific materials, including publications, presentations and promotional content, ensuring compliance with regulatory standards

What We Are Looking For

Baseline Skills, Experiences, & Attributes:

  • Bachelor’s degree or equivalent in the life sciences, healthcare, or related field is required. Advanced degree in Vision Sciences, Biology, Engineering, Clinical Research or similar field is plus
  • Domain expertise in clinical research design related to Ophthalmology strongly desired
  • 8+ years of technical, hands-on clinical operations experience at a medical device company with a strong track record of successful trial initiation and execution  
  • Demonstrated extensive understanding of clinical trial processes, and technical expertise in driving execution, from study start-up through study closure
  • Thorough knowledge and understanding of FDA and/or EMA regulations (or relevant local regulations), ICH Guidelines and GCPs governing the conduct of clinical trials
  • Working experience with an electronic data capture system, CTMS system, and eTMF system
  • Prior experience with commercial medical product clinical studies, the creation and execution of clinical projects, FDA validation, and understanding of clinical workflow towards product incorporation
  • Strong interpersonal communication (written and verbal), organizational and prioritization skills for both internal and external entities. Must be able to work in a team environment.
  • Demonstrated ability to understand, evaluate and interpret data

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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