Apply on Employer Site

Shifamed · 6 hours ago

Sr. Clinical Research Associate (Field)

California, United States

Full-time

Hybrid

Mid, Senior Level

$120K/yr - $140K/yr

5+ years exp

Shifamed is a medical device innovation hub focused on developing novel medical products. They are seeking two Senior Clinical Research Associates to monitor and manage clinical trial site activities, ensuring compliance with protocols and regulatory requirements while maintaining data integrity and participant safety.

Health CareMedical Device

Growth Opportunities

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

Qualification

Clinical research experienceIndependent monitoringGCPEDC proficiencyCardiovascular device studiesStakeholder managementInterpersonal skillsCommunication skills

Required

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