Clinical Research Associate (IVD/Medical Devices)

Location: Fully remote within the United States; travel within the US is required for 20–70% of the role, including overnight travel.

Salary: $75,000–$95,000 annually, plus bonus or incentive pay.

Company

hirify.global develops diagnostics and life sciences technologies through its diagnostics operating companies and global clinical affairs organization.

What you will do

• Lead IVD and medical device clinical study execution from site start-up through close-out.
• Monitor external clinical research sites and laboratories for protocol compliance, data quality, investigational product accountability, and issue resolution.
• Build and maintain relationships with investigators, institutions, vendors, and cross-functional stakeholders.
• Manage IRB/IEC submissions, amendments, and regulatory documentation.
• Support site identification, qualification, activation, contract and budget negotiations, and process improvement.
• Drive corrective and preventive actions for protocol deviations and adverse events.

Requirements

• Bachelor’s degree in life sciences, healthcare, or a related field with 3+ years of clinical research experience, or a master’s degree with 2+ years of related experience.
• Knowledge of regulatory requirements and Good Clinical Practice.
• Experience with IVD and medical device clinical trials is preferred.
• Strong technical skills and the ability to use current and emerging technologies.
• Ability to manage multiple projects simultaneously.
• Ability to travel 20–70% within the United States, with overnight travel when required.

Nice to have

• Experience with electronic Trial Master Files, Electronic Data Capture systems, and Clinical Trial Management Systems.
• Knowledge of CLSI guidelines and Good Laboratory Practice.
• Experience in neurological disease research.

Culture & Benefits

• Remote work arrangement from a home office within the United States.
• Paid time off and medical, dental, and vision insurance for eligible employees.
• 401(k) benefits for eligible employees.
• Work within a global clinical affairs organization focused on diagnostics and life sciences innovation.