Senior Specialist, Clinical Research Monitoring

This is a fully remote position, open to applicants in Arizona, +2 more states.

📋 Description

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

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

• Assess whether subject documentation corresponds with the study hypotheses.

• Supervise clinical trial/study safety in accordance with protocols, Good Clinical Practice (GCP), and regulatory standards.

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

• Mentor, train, and guide new or junior staff members.

• Offer oversight and insights into trial activities, including protocol adherence, enrollment, monitoring deviations, and data integrity.

• Communicate trial insights to principal investigators, support personnel, sponsor management, leadership, and ethics committees.

• Develop enhancements to processes.

• Contribute to clinical protocols, informed consent documents, and case report forms.

• Validate accountability of investigational devices from Edwards to field sites through final disposition.

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

• Conduct audits of sites for necessary regulatory documentation and proper source documentation.

• Edit and revise informed consent documents.

⛳️ Requirements

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

• Willingness to travel up to 75% domestically.

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

• Strong written and verbal communication abilities, along with presentation, interpersonal, and analytical skills.

• Proven problem-solving and critical thinking capabilities.

• Proficient in MS Office Suite, including Word, Excel, and Adobe, and capable of operating general computer software and office equipment.

• Excellent understanding of cardiovascular anatomy, pathology, and physiology, or relevant expertise in the Business Unit.

• Moderate knowledge of medical device regulatory requirements and documentation, device accountability, and adverse event reporting.

• Competence in technical writing (protocols, CRF development, study tools).

• Ability to effectively communicate and build relationships with key opinion leaders and clinical personnel.

• Experience in onboarding and training new employees.

🏝️ Benefits

• Competitive salaries.

• Performance-based incentives.

• A diverse range of benefits programs designed to meet the individual needs of employees and their families.