Note: The job is a remote job and is open to candidates in USA. Supira Medical, a clinical-stage Shifamed Portfolio Company, is focused on developing innovative medical devices for cardiology. They are seeking a Senior Clinical Research Associate to monitor and manage clinical trial site activities, ensuring compliance with protocols and regulatory standards while contributing to the success of clinical trials.
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 strongly preferred
- Prior experience in cardiovascular or interventional device studies strongly preferred
Benefits
- Equity
- Benefits
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