Senior Specialist, Clinical Research Monitoring

Edwards Lifesciences • USA-California-Remote, CA

2d • $108,000 - $153,000

About The Position

As part of the Clinical Affairs team, the Senior Specialist, Clinical Research Monitoring helps generate clinical evidence demonstrating the effectiveness and safety of innovations and their impact on patients. The role partners with principal investigators, medical professionals, patient advocacy groups, and regulatory authorities to support evidence generation and optimize patient outcomes.

The position conducts field monitoring and data collection for clinical trials, reviews study documentation for consistency and protocol compliance, and monitors study safety in accordance with protocols, Good Clinical Practices (GCP), and regulatory requirements. It also provides technical training and mentoring, offers oversight and insights into trial activities, verifies data and regulatory documentation, tracks investigational device accountability, and edits or amends informed consent documents.

Requirements

• Bachelor's degree or equivalent in a related field, with 5 years of field monitoring, quality assurance/control, and regulatory compliance experience; equivalent work experience may be considered based on Edwards criteria.
• Ability to travel up to 75% domestically.

Nice To Haves

• Clinical research certification, such as ACRP or SoCRA clinical coordinator or CRA certification.
• Experience in clinical trials of medical devices.
• Excellent written and verbal communication, presentation, interpersonal, and analytical skills.
• Demonstrated problem-solving and critical-thinking skills.
• Proven expertise in MS Office Suite, including Word, Excel, and Adobe, and ability to operate general computer software and office machinery.
• Excellent understanding of cardiovascular anatomy, pathology, and physiology, or the relevant Business Unit area of expertise.
• Understanding of medical device regulatory requirements and documents, device accountability, and adverse event reporting.
• Technical writing skills, including protocols, CRF development, and study tools.
• Ability to communicate and relate well with key opinion leaders and clinical personnel.
• Experience training new hires.

Responsibilities

• Conduct field monitoring and data collection for clinical trials.
• Assess data documentation, reports, records, transcripts, and examination results for consistency with case report forms and study hypotheses.
• Monitor clinical trial safety and compliance with protocols, Good Clinical Practices (GCP), and regulatory requirements.
• Develop and deliver technical training on GCP, protocols, databases, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, and regulatory documentation requirements.
• Train and proctor new employees on trial- and study-related activities, and mentor new or junior-level employees.
• Provide principal investigators, support staff, sponsor management, and leadership with oversight and insights into trial activities, including protocol compliance, enrollment, monitoring deviations, and data quality.
• Develop process improvements based on trial oversight and insights.
• Validate investigational device accountability by tracking devices from Edwards to field sites through final disposition.
• Verify trial and study data and maintain appropriate internal and external regulatory documents.
• Audit sites to ensure they have appropriate regulatory documentation and that source documentation is properly recorded.
• Edit or amend informed consent documents.

Benefits

• Competitive salaries
• Performance-based incentives
• A wide variety of benefits programs to address the diverse individual needs of employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Senior