Alimentiv is hiring a
Sr. Clinical Research Associate

Summary

The job description is for a Clinical Research Associate (CRA) or Lead CRA position within Alimentiv. The individual will manage, deliver, and perform full clinical site monitoring services for one or more projects, act as a subject matter expert, mentor, and coach, lead project monitoring teams, handle site recruitment and setup, and ensure investigational sites are compliant with project specific requirements.

Requirements

• The successful candidate will possess a minimum of a college diploma/degree and 4-6 years of related experience
• The successful candidate must exhibit the following skills: 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

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
• When required, act as the first escalation point for the resolution of site/patient issues or to address Sponsor concerns
• May represent Director, Monitoring and Site Management or Manager, Clinical Site Management in BD initiatives with a site monitoring focus
• May be assigned Lead CRA role and manage monitoring services for a group of projects and/or CRAs on large/complex project(s) including directing/guiding day to day activities and review/approval of monitoring reports
• 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, including investigational product, protocols, SOPs, CRFs, project documents, forms and support tools
• Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria
• Primary clinical site contact. May act as primary contact for any questions or issues that arise from investigational sites
• 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

Benefits

• Home-based
• Moderate travel
• $75,000 - $124,000 a year + Bonus