Clinical Research Monitoring Specialist

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

📋 Description

• Perform field observations and data gathering for clinical trial studies.

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

• Assess whether the documentation of clinical trial/study subjects corresponds with the study hypothesis.

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

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

• Communicate findings to principal investigators, support personnel, sponsor management, leadership, Institutional Review Boards/Ethics Committees, Research Ethics Committees, and Clinical Operations.

• Suggest and formulate process enhancements.

• Verify trial/study data and ensure the maintenance of relevant internal and external regulatory documents.

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

• Confirm investigational device accountability from Edwards through field sites and oversee final disposition.

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

• Educate and supervise new employees on trial- and study-related tasks.

⛳️ Requirements

• Bachelor's Degree or equivalent in a relevant field.

• A minimum of 3 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% within the country.

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

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

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

• Demonstrated skills in problem-solving and critical thinking.

• Solid understanding of cardiovascular anatomy, pathology, physiology, or the specific Business Unit area of expertise.

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

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

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

🏝️ Benefits

• Competitive salaries.

• Performance-based incentives.

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