Clinical Trial Specialist

About Optain

Optain is a revolutionary healthcare company that uses groundbreaking software and hardware technology to rethink care. We use the eye as a window to the body to improve the way we detect and manage eye and systemic conditions. Optain is committed to expanding and improving care through the introduction of AI and machine learning technology frontline care settings at an accessible price. This not only promotes greater access to care, but promises to reduce the strains of overburdened healthcare systems.

Originally founded in Australia in 2019, Optain seeks to commercialize the inventions of Professor Mingguang He, a preeminent clinician-scientist and scholar in the field of ophthalmology. Optain has achieved regulatory approval and commercial adoption of its product suite in global markets, including Australia, Europe, and more.

In 2025, Optain received US FDA clearance for its Resolve retinal camera. Optain also recently closed a Series A funding round led by Insight Partners with participation from seven leading U.S. health system investors, including Memorial Hermann Health System, Northwell Health, Novant Health, The Ohio State University Wexner Medical Center, and UPMC. These systems collectively deliver care to 28 million patients across 25 states and have begun deploying Optain's platform across their networks, rapidly accelerating the company's footprint and expanding screening access nationwide.

● About Optain

About the Job

The Clinical Trial Specialist will support the planning and execution of clinical studies for AI-enabled disease detection. This role bridges clinical trial administration and site-facing activities, providing critical support in study execution, data quality, and regulatory compliance.  The CTS will collaborate closely with Clinical Operations, Regulatory and Product teams in support of regulatory submissions and commercialization goals.

This is a fully remote position based in the United States with up to 30% travel for site visits, training activities or company meetings. Occasional international travel may be required.

What You'll Do:

• Support site start-up activities, including creation of study templates, CRFs, study manuals, site shipments, investigator binders and investigational device accountability.
• Support data entry, query tracking, and remote and on-site monitoring needs in collaboration with CRO and internal team members.
• Support or lead IRB submissions. 
• Maintain essential documents in the Trial Master File (TMF) per regulatory and company standards.
• Coordinate clinical trial logistics such as meeting scheduling, site communications, and shipping of study materials.
• Collaborate with CRO, central reading centers and other vendors as needed.
• Draft and distribute study-related communications, agendas, and minutes.
• Ensure adherence to GCP, ISO 14155, and regulatory guidelines with supervision.
• Assist in the preparation of clinical study reports, presentations, and regulatory submissions.
• Contribute to the development of SOPs, templates, and internal workflows.

What You'll Need:

• Bachelor’s degree in life sciences, health, or related field.
• 2-5 years of clinical research experience, preferably in medical devices or diagnostics.
• Good Clinical Practice (GCP) certification
• Ophthalmology knowledge is preferred. Prior photography and/or imaging experience, IRB experience, and data management experience is also preferred
• Knowledge of 21 CFR and ISO 14155 requirements is preferred
• SOCRA or ACRP certification is preferred

What You'll Bring to the Table:

• Strong organizational, communication, and problem-solving skills.

Benefits & Perks:

• Competitive compensation package, including a strong base salary, performance-based bonus, and the chance to earn upside.
• Top-tier health, vision, dental, and commuter benefits.
• Generous monthly health and wellness reimbursement.
• Unparalleled exposure to new business building at the intersection of artificial intelligence and healthcare.
• Mentorship, clinical operations training with increasing exposure to site-facing activities. 
• A chance to work with a highly talented, close-knit team and dedicated mentors who can guide you on your career path.

Salary Range:

• $85,000 - $125,000 base salary, depending on experience and alignment with role expectations.

Why Optain? Make a real difference: Your work will help solve difficult problems as you collaborate with world-class experts from healthcare provider networks, academia, and industry. Join Optain in transforming healthcare with AI!