Clinical Research Associate (CRA, IVD & Medical Devices)

Location: Fully remote within the United States; requires 20–70% travel within the US, including overnight travel.

Annual salary: $85,000–$95,000, plus eligibility for bonus or incentive pay.

Company

hirify.global develops life sciences, diagnostics, biotechnology, and medical technology solutions focused on improving diagnostic results and patient care.

What you will do

• Oversee IVD and medical device clinical study execution at external sites from start-up through close-out.
• Ensure timely data collection, data integrity, protocol compliance, FDA requirements, and Good Clinical Practice standards.
• Build relationships with institutions, investigators, internal stakeholders, and vendors.
• Conduct site monitoring, coordinate study activities, manage investigational product accountability, and assess protocol deviations and adverse events.
• Manage IRB submissions and regulatory documentation, and prepare clinical study templates and monitoring plans.
• Support study planning through budget and timeline forecasts, site identification and qualification, and process improvement.

Requirements

• Bachelor’s degree with 2+ years of clinical research experience, or a master’s degree with 0–2 years of clinical research experience.
• Knowledge of regulatory requirements and Good Clinical Practice for in vitro diagnostic and medical device products.
• Experience managing clinical research sites and monitoring clinical study data.
• Technical background sufficient to understand and communicate current and emerging technologies.
• Ability to manage multiple projects simultaneously.
• Ability to work remotely from within the United States and travel 20–70% domestically.

Nice to have

• Experience with retrospective or prospective biological sample procurement.
• Experience with electronic Trial Master Files and Clinical Trial Management Systems.
• Understanding of CLSI standards and their application to IVD clinical studies, including method comparison, precision and reproducibility, reference intervals, specimen stability, clinical performance, and point-of-care evaluations.

Culture & Benefits

• Remote work arrangement from a home office for eligible roles.
• Paid time off and medical, dental, and vision insurance.
• 401(k) benefits for eligible employees.
• Continuous improvement culture focused on translating scientific innovation into practical impact.