Clinical Research Associate II

As the Clinical Research Associate II, you will support clinical studies through hands-on site monitoring and study management. In this role, you will serve as a primary contact for clinical research sites and oversee activities across the study lifecycle, helping ensure clinical data integrity and compliance with applicable regulatory requirements, study protocols, and company procedures.

What You Will Do

• Manage assigned clinical research sites throughout the study lifecycle, serving as the primary point of contact for site personnel.
• Conduct site qualification/selection assessments, site initiation, interim monitoring, and closeout visits independently and document findings within required timelines.
• Monitor clinical study data and source documentation to verify accuracy, completeness, traceability, and compliance with study protocols.
• Evaluate site activities against Good Clinical Practice, FDA, ISO, and other applicable clinical research and regulatory requirements.
• Identify, document, and follow up on protocol deviations, data discrepancies, compliance issues, and corrective actions through resolution.
• Coordinate with investigators, clinical research coordinators, study teams, and cross-functional partners to support study execution and address site-level issues.
• Maintain required clinical trial documentation and site records in accordance with study procedures, regulatory requirements, and established quality standards.
• Track site progress, enrollment activities, monitoring findings, and outstanding deliverables to support study timelines and clinical trial objectives.

What You Need

Required

• Bachelor's degree in a science, healthcare, life sciences, or related field, or equivalent education.
• Minimum 4 years of relevant clinical research experience, including direct clinical site monitoring experience.
• Experience independently conducting site qualification/selection assessments, site initiation, interim monitoring, and/or closeout visits.
• Experience applying Good Clinical Practice, FDA, ISO, or related clinical research requirements to clinical trial activities and documentation.

Preferred

• Certified Clinical Research Associate (CCRA) certification.
• Experience in the medical device or pharmaceutical industry.
• Previous experience as a Clinical Research Associate, Clinical Research Coordinator, or Clinical Trial Coordinator.
• Experience supporting orthopedic clinical research or orthopedic medical devices.