Clinical Research Associate (MedTech)

Location: Audubon, Pennsylvania, United States; requires remote and on-site monitoring activities and travel up to 70% of the time.

Company

hirify.global develops medical technology and surgical solutions designed to improve outcomes for patients with musculoskeletal disorders.

What you will do

• Conduct site qualification, initiation, interim monitoring, and closeout visits in accordance with study protocols, GCP, regulations, and company procedures.
• Review source documents, verify clinical data, assess protocol compliance, and identify and escalate adverse events, deviations, and other study issues.
• Monitor site enrollment, retention, performance, data quality, and corrective and preventive actions; collaborate with investigators and site personnel on issue resolution.
• Maintain productive relationships with investigators, site staff, sales representatives, study leadership, and internal stakeholders.
• Support the development and maintenance of protocols, case report forms, informed consent forms, EDC systems, source documents, training materials, and monitoring plans.
• Contribute to process improvement, study team meetings, cross-functional initiatives, and clinical operations best practices.

Requirements

• Bachelor's degree in a scientific, healthcare, engineering, or related discipline, or an equivalent combination of education and relevant clinical research experience.
• 1–3 years of clinical research experience in the medical device, biotechnology, or pharmaceutical industry, including direct clinical study monitoring.
• Working knowledge of clinical research principles, Good Clinical Practice, and applicable clinical study regulations.
• Strong communication, organizational, analytical, problem-solving, collaboration, and attention-to-detail skills.
• Proficiency with Microsoft Office; familiarity with EDC systems, CTMS, or other clinical research technologies is preferred.
• Ability to travel up to 70% of the time and perform both remote and on-site monitoring activities.

Nice to have

• Familiarity with FDA regulations, ISO 14155, EU MDR requirements, or other applicable clinical research regulations.
• Experience with EDC systems, CTMS, or other clinical research technologies.

Culture & Benefits

• Collaborative, solutions-oriented environment focused on teamwork and cross-functional partnership.
• Work guided by values of innovation, customer focus, teamwork, and driven execution.
• Commitment to ethical business practices, regulatory compliance, inclusion, and respect.
• Reasonable accommodations are available for individuals with disabilities.