Senior Specialist, Clinical Research Monitoring

This is a fully remote position, open to applicants in California.

📋 Description

• Execute field monitoring for studies and gather data for clinical trials.

• Evaluate data documentation, reports, records, transcripts, and examination results for alignment with case report forms and study hypotheses.

• Oversee clinical trial/study safety in compliance with protocols, Good Clinical Practices (GCP), and regulatory standards.

• Create and present technical training on GCPs, protocols, databases, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, and regulatory documentation requirements.

• Onboard and supervise new employees, while mentoring junior staff members.

• Provide oversight and insights into trial operations, including protocol adherence, enrollment, monitoring deviations, and data quality.

• Communicate insights to principal investigators, support personnel, sponsor management, leadership, Institutional Review Boards/Ethics Committees/Research Ethics Boards, and training teams.

• Identify and implement process enhancements.

• Ensure investigational device accountability by monitoring devices from Edwards to field locations through to final disposition.

• Confirm trial/study data accuracy and maintain necessary internal and external regulatory documents.

• Conduct audits of sites to ensure appropriate regulatory documentation and accurate source documentation.

• Revise and update informed consent documents.

⛳️ Requirements

• Bachelor's Degree or equivalent in a related field with 5 years of experience in field monitoring, quality assurance/control, and regulatory compliance, or equivalent work experience in line with Edwards criteria.

• Willingness to travel up to 75% domestically.

• Clinical research certification (ACRP or SoCRA clinical coordinator/CRA certification) is preferred.

• Experience in clinical trials involving medical devices is preferred.

• Strong written and verbal communication, presentation, interpersonal, and analytical skills are preferred.

• Proven problem-solving and critical thinking abilities are preferred.

• Proficient in MS Office Suite, including Word, Excel, and Adobe, with the capability to operate standard computer software and office equipment preferred.

• Comprehensive understanding of cardiovascular anatomy, pathology, and physiology or relevant Business Unit expertise is preferred.

• Familiarity with medical device regulatory requirements and associated documents, device accountability, and adverse event reporting is preferred.

• Proficient technical writing skills (protocols, CRF development, study tools) are preferred.

• Ability to effectively communicate and establish rapport with key opinion leaders and clinical personnel is preferred.

• Experience in training new employees is preferred.

🏝️ Benefits

• Competitive salaries.

• Performance-based incentives.

• A diverse array of benefits programs for employees and their families.