Clinical Research Associate

Essential Functions

• Conducts remote and on-site monitoring activities, including site qualification visits, site initiation visits, interim monitoring visits, and closeout visits, in compliance with standard operating procedures and applicable regulatory requirements.
• Develops monitoring expertise through ongoing training and collaboration with senior clinical team members.
• Reviews source documentation, verifies study data, evaluates protocol compliance, and ensures timely identification, documentation, and escalation of study issues, including adverse events, protocol deviations, and corrective and preventive actions.
• Monitors site enrollment, retention, protocol compliance, and data quality metrics; identifies site performance issues and collaborates with investigators, site personnel, and study leadership to support timely resolution.
• Supports site compliance with study protocols, Good Clinical Practice (GCP), applicable regulations, company procedures, and sponsor requirements through routine monitoring, issue identification, and follow-up activities.
• Establishes and maintains productive working relationships with investigators, site personnel, sales representatives, and internal stakeholders to support study execution, evaluate site feasibility, and promote successful study outcomes.
• Supports the development, review, and maintenance of study documents for assigned studies, including clinical study protocols, case report forms and subject questionnaires, informed consent forms, electronic data capture (EDC) systems, and other study tools.
• Participates in process improvement initiatives and contributes feedback to support the enhancement of clinical operations procedures, tools, templates, and best practices.
• Contributes to a highly collaborative and solutions-oriented team culture by actively participating in study team meetings, sharing site-level updates and insights, and supporting cross-functional initiatives.
• Demonstrates a positive attitude, adaptability, and a willingness to contribute to departmental projects and organizational priorities as needed.
• Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
• Ensures compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to the role.
• Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties.

Qualifications

• Excellent verbal, written, and interpersonal communication skills, with a demonstrated ability to collaborate effectively across functions and contribute to a positive, team-oriented culture.
• Bachelor's degree in a scientific, healthcare, engineering, or related discipline; equivalent combination of education and relevant clinical research experience may be considered.
• Minimum of 1-3 years of experience in clinical research within the medical device, biotechnology, or pharmaceutical industry, including direct experience monitoring clinical studies.
• Working knowledge of clinical research principles, Good Clinical Practice (GCP), and applicable regulations governing clinical studies.
• Familiarity with FDA regulations, ISO 14155, EU MDR requirements, and/or other applicable clinical research regulations preferred.
• Strong organizational, analytical, and problem-solving skills, with the ability to manage multiple priorities, meet deadlines, and maintain attention to detail in a fast-paced environment.
• Proficiency with Microsoft Office applications; experience with electronic data capture (EDC), clinical trial management systems (CTMS), or other clinical research technologies preferred.
• Ability to travel up to 70% of the time.