Overview
Conduct clinical research monitoring for cardiovascular medical device studies, ensuring data quality, regulatory compliance, safety, and proper investigational device accountability.
What you'll do
- Monitor clinical studies and assess trial documentation against case report forms and study protocols.
- Monitor study safety, protocol compliance, enrollment, deviations, and data quality.
- Verify regulatory and source documentation and audit site records.
- Track investigational devices from Edwards through field sites to final disposition.
- Develop and deliver training on GCPs, protocols, databases, compliance, adverse-event reporting, and regulatory documentation.
- Recommend and develop clinical trial process improvements.
What you'll need
- Hold a bachelor's degree or equivalent in a related field.
- Have 3 years of field monitoring, quality assurance/control, and regulatory compliance experience or equivalent work experience.
- Be able to travel up to 75% domestically.
- Understand medical device regulatory requirements, device accountability, and adverse-event reporting.
- Demonstrate written, verbal, presentation, interpersonal, analytical, problem-solving, and critical-thinking skills.
- Have proficiency with MS Office Suite, including Word, Excel, and Adobe.
Nice to have
- Clinical research certification from ACRP or SoCRA.
- Understanding of cardiovascular anatomy, pathology, and physiology.
- Technical writing experience with protocols, CRF development, or study tools.
- Experience communicating with key opinion leaders and clinical personnel.
Details
- Remote in the United States.
- Base pay range: $87,000–$123,000 yearly.
Read the full description and apply on the company’s own careers page.
NewPosted today
