Remote Clinical Operations Lead

Summary

The job is for a Clinical Operations Lead responsible for overseeing project deliverables, providing oversight to CRAs and investigator sites, developing study tools, and supporting other objectives for clinical operations. The role requires a college diploma/degree with 7-9 years of experience or an undergraduate university degree with 4-6 years' experience.

Requirements

College diploma/degree AND 7-9 years related experience OR Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience

Responsibilities

• Oversee project deliverables, assigned CRAs and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations
• Develop study tools for site and CRA use, review visit reports, review and track protocol deviations
• Implement enrollment and recruitment strategies, prepare the monitoring plan and other structural documentation, oversee monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions

Preferred Qualifications

Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation

Benefits

Home-based