Remote Clinical Operations Lead

Summary

Join Alimentiv as a Clinical Operations Lead (COL) responsible for overseeing the clinical operations of a project within a defined regional/global level. Provide oversight to CRAs and investigator sites, develop study tools, review visit reports, and support other objectives for clinical operations.

Requirements

• Fluent in the reading, writing, and speaking of English
• Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training

Responsibilities

• Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations
• Conducts assessment visits with CRAs
• Implements enrollment and recruitment strategies
• Prepares the monitoring plan and other structural documentation
• Oversees monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions
• Develops study tools for site and CRA use
• Reviews visit reports, reviews and tracks protocol deviations
• Supports other objectives for clinical operations and the clinical project team

Preferred Qualifications

• Health Sciences, Life Sciences or Nursing specialty preferred
• Or SoCRA and/or ACRP Certification/Designation
• Should have a minimum of 3 years CRA experience
• Have strong experience with EDC systems
• Be proficient with MS Office
• Have strong written and verbal communication skills and highly effective interpersonal and organizational skills

Benefits

Home-based