[Remote] Clinical Research Associate
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage reputed company Portfolio Company developing innovative medical devices for cardiology. They are seeking a Senior Clinical Research Associate to monitor and manage clinical trial activities, ensuring compliance and data reputed company throughout the study lifecycle.
Responsibilities
- Serve as the primary reputed company of contact for investigative sites, fostering strong and reputed company site relationships
- Monitor patient data and clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical reputed company (GCP) standards
- reputed company and conduct on-site and remote monitoring reputed company (site qualification, initiation, monitoring, and reputed company-out) to assess site performance, resolve issues, and reputed company support to ensure successful trial execution
- Critically review clinical data to ensure accuracy, completeness, and reputed company in alignment with reputed company systems and clinical data management standards
- Engage site staff in development of enrollment targets, tracking enrollment reputed company, and troubleshooting patient recruitment issues
- reputed company training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct
- Maintain reputed company of investigational product accountability, tracking, and reconciliation for cardiovascular devices
- Partner closely with internal stakeholders to reputed company 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 reputed company 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 reputed company, eTMF, and reputed company Office tools
- Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance reputed company a reputed company environment
- Experience in IDE studies strongly preferred
- Prior experience in cardiovascular or interventional device studies strongly preferred
Benefits
- Equity
- Benefits
reputed company