Clinical Research Associate (Medical Devices)

Location: Austin, Texas, United States; up to 30% travel, with domestic and occasional international site visits.

Base salary: $89,000–$148,000 USD per year, plus equity compensation for full-time employees.

Company

hirify.global develops brain-computer interface devices intended to restore movement and sight and transform interaction with digital systems.

What you will do

• Conduct site initiation, interim monitoring, and close-out visits both remotely and on site.
• Ensure clinical studies comply with protocols, GCP, ISO 14155, and applicable FDA regulations, including 21 CFR Part 812.
• Verify clinical trial data through source data verification and source data review.
• Monitor adverse events, serious adverse events, device deficiencies, enrollment, site performance, and data quality.
• Maintain Investigator Site Files, informed consent forms, monitoring reports, and other essential documentation.
• Support site training, data query resolution, protocol deviation management, audit readiness, and cross-functional coordination.

Requirements

• Bachelor’s degree in life sciences, engineering, or a related field.
• 5+ years of clinical research experience; medical device experience is strongly preferred.
• Working knowledge of GCP, ICH E6, ISO 14155, and applicable FDA regulations.
• Experience with electronic data capture systems and clinical trial documentation.
• Strong understanding of clinical trial monitoring and site management processes.
• Excellent communication, organizational, problem-solving, and independent-working skills.

Nice to have

• Experience with neuromodulation, implantable devices, or Class III medical devices.
• Experience supporting IDE or PMA clinical studies.
• Familiarity with risk-based monitoring, early feasibility or first-in-human studies, and market approval studies.
• Willingness and ability to travel up to 30–50% domestically and internationally.

Culture & Benefits

• Cross-functional work across Clinical Operations, Data Management, Regulatory, Quality, engineering, and medicine.
• Medical, dental, and vision insurance through a PPO plan.
• Paid holidays, flexible time off, commuter benefits, meals, parental leave, and a 401(k) plan.
• Equity compensation through Restricted Stock Units for full-time employees.
• Opportunities for professional growth and advancement based on impact.