Sr. Clinical Research Associate

Monitoring - Subject Expert

• 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.

Project Monitoring Lead

• 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.

Site Recruitment and Setup

• 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.

Investigational Site Monitoring

• 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.

Qualifications

• The successful candidate will possess a minimum of a college diploma/degree and 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.
• Critical thinking abilities
• Ability to regularly travel to sites.

Working Conditions

• Home-based
• Regular travel is required