Remote Clinical Research Associate

Summary

Join our team as a Clinical Site Monitoring Lead and be responsible for managing, delivering, and performing full clinical site monitoring services. As a subject matter expert, mentor, coach, and performance feedback provider, you will assist with selection, hiring, training, and supervision of CRAs. You may also represent the corporation in BD initiatives and participate in project planning, protocol development, and communication.

Requirements

• Minimum of a college diploma/degree
• 4-6 years of related experience
• Self-motivation with strong communication skills and a commitment to achieving positive results
• Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results
• Ability to engage in continuous learning and self-development
• Ability to continually foster teamwork
• Fluent in the reading, writing and speaking of English

Responsibilities

• Manage, deliver and/or perform full clinical site monitoring services for one or more projects
• Act as subject matter expert, mentor, coach and/or provide performance feedback to manager for peers
• Assist with selection, hiring, training, and supervision of CRAs as needed
• Perform co-monitoring and training visits with CRAs
• Act as the first escalation point for the resolution of site/patient issues or to address Sponsor concerns
• Represent Director, Monitoring and Site Management or Manager, Clinical Site Management in BD initiatives with a site monitoring focus
• Function as liaison between CRAs and other functional teams, escalating concerns and issues to management as needed
• Participate and/or present at study team, kickoff and investigator meetings and act as primary contact to sponsors for all monitoring related issues
• Identify and recruit site investigators, coordinate the movement and delivery of trial materials, samples, tests and forms
• Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria
• Oversee overall integrity of the study to promote positive working relationships with the site and staff
• Facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements
• Ensure all site related issues are followed until resolution
• Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project lifecycle