Clinical Trial Specialist (Medtech)

TL;DR

Clinical Trial Specialist (Medtech): Supporting the planning and execution of clinical studies for AI-enabled eye disease detection with an accent on regulatory compliance, data quality, and site-facing operations. Focus on maintaining Trial Master File standards, coordinating logistics for device clinical trials, and supporting regulatory submissions in the medical device field.

Location: Must be based in the United States; up to 30% travel required.

Salary: $85,000–$125,000

Company

hirify.global is a healthcare technology company commercializing AI-driven diagnostic solutions for eye and systemic conditions, backed by major US health systems.

What you will do

• Manage site start-up activities including creation of study templates, CRFs, and investigator binders.
• Oversee data entry, query tracking, and monitoring needs in coordination with CROs.
• Maintain essential documentation in the Trial Master File according to regulatory standards.
• Lead or support IRB submissions and ensure adherence to GCP and ISO 14155 guidelines.
• Coordinate clinical trial logistics, site communications, and study material shipments.
• Assist in drafting clinical study reports and presentations for regulatory submissions.

Requirements

• Bachelor’s degree in life sciences or related field required.
• 2-5 years of clinical research experience in medical devices or diagnostics.
• Current Good Clinical Practice (GCP) certification.
• Must be based in the United States and able to travel up to 30%.
• Strong knowledge of 21 CFR and ISO 14155 requirements.

Nice to have

• Ophthalmology industry experience.
• Prior experience with photography, medical imaging, or IRB management.
• SOCRA or ACRP certification.

Culture & Benefits

• Competitive compensation including base salary, performance-based bonus, and upside potential.
• Comprehensive health, vision, and dental benefits.
• Monthly health and wellness reimbursement.
• Exposure to AI-driven business building and mentorship from industry experts.
• Flexible work environment with a collaborative, high-impact team.