Specialist, Clinical Research Monitoring - Remote

Overview

The Specialist in Clinical Research Monitoring ensures the safety of trial patients by conducting ethical trials that adhere to regulatory compliance, data accuracy, and protocol adherence.

In Short

• Field monitoring of studies and data collection for clinical trials.
• Assess data documentation and ensure consistency with case report forms.
• Provide oversight of trial activities and recommend process improvements.
• Verify trial/study data and maintain regulatory documents.
• Validate investigational device accountability.
• Develop and deliver training on GCPs and compliance.
• Contribute to the development of clinical protocols and consent forms.
• Edit and amend informed consent documents.
• Strong communication and analytical skills required.
• Experience in a medical device or regulated industry is essential.

Requirements

• Bachelor's Degree or equivalent in a related field.
• 3 years of field monitoring experience.
• Experience with quality assurance/control and regulatory compliance.
• Experience with electronic data capture.
• Strong written and verbal communication skills.
• Proven expertise in MS Office Suite.
• Demonstrated problem-solving and critical thinking skills.
• Understanding of cardiovascular anatomy and medical device regulatory requirements.
• Technical writing skills are a plus.
• Adhere to company rules and safety protocols.

Benefits

• Work with a global leader in patient-focused medical innovations.
• Collaborate with leading clinicians and researchers.
• Contribute to improving patient outcomes and enhancing lives.
• Extensive operations in North America, Europe, Asia, and Latin America.
• Opportunities for professional development and training.
• Supportive work environment focused on safety and compliance.
• Engage in meaningful work that impacts patient health.