Clinical Trial Specialist
About The Position
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.
Requirements
- 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
- Strong organizational, communication, and problem-solving skills.
Nice To Haves
- 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
Responsibilities
- 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.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1-10 employees
