Senior Clinical Research Associate (IVD/Medical Devices)

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

Annual salary: $103,000–$130,000, plus bonus or incentive pay.

Company

hirify.global develops life sciences, diagnostics, and biotechnology solutions, with a focus on expanding access to precision diagnostics.

What you will do

• Oversee IVD and medical device clinical study execution at external sites from start-up through close-out.
• Train and manage clinical research sites while maintaining relationships with investigators, institutions, vendors, and internal stakeholders.
• Conduct independent monitoring, including site coordination, investigational product accountability, protocol deviation and adverse event assessment, and data quality follow-up.
• Manage IRB submissions and regulatory documentation, keeping the Trial Master File current and audit ready.
• Support study planning, including budgets, contracts, timelines, site qualification, process improvements, and preparation of clinical study documents.

Requirements

• Bachelor’s degree with 5+ years of clinical research experience, or a master’s degree with 3+ years of experience, or a doctoral degree with 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 and travel within the United States as required.

Nice to have

• Experience with retrospective or prospective biological sample procurement.
• Experience using electronic Trial Master Files and Clinical Trial Management Systems.
• Knowledge of CLSI standards and their application to IVD clinical studies.

Culture & Benefits

• Flexible remote work arrangement from a home office.
• Paid time off and medical, dental, and vision insurance for eligible employees.
• 401(k) benefits for eligible employees.
• Culture focused on continuous improvement, scientific innovation, and belonging.