Note: The job is a remote job and is open to candidates in USA. Supira Medical is seeking a field-based Senior Clinical Research Associate to monitor and manage clinical trial site activities. The role supports protocol compliance, regulatory requirements, data integrity, participant safety, and successful trial execution throughout the study lifecycle.

Responsibilities

• Serve as the primary point of contact for investigative sites, fostering strong and collaborative site relationships
• Monitor patient data and clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
• Lead and conduct on-site and remote monitoring visits (site qualification, initiation, monitoring, and close-out) to assess site performance, resolve issues, and provide support to ensure successful trial execution
• Critically review clinical data to ensure accuracy, completeness, and integrity in alignment with EDC systems and clinical data management standards
• Engage site staff in development of enrollment targets, tracking enrollment progress, and troubleshooting patient recruitment issues
• Provide training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct
• Maintain oversight of investigational product accountability, tracking, and reconciliation for cardiovascular devices
• Partner closely with internal stakeholders to align clinical activities with business and regulatory objectives
• Identify, document, and assist in resolving protocol deviations and CAPAs
• Participate in internal audits and support readiness for regulatory inspections

Skills

• Bachelor's degree in life sciences, nursing, biomedical engineering, or related discipline
• 5+ years of experience in clinical research, including at least 3 years of independent monitoring for medical device trials
• Strong working knowledge of GCP, ISO 14155 and FDA guidelines
• Proficient in EDC, eTMF, and Microsoft Office tools
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment
• Experience in IDE studies
• Prior experience in cardiovascular or interventional device studies

Benefits

• Equity
• Full-time remote position

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