Clinical Operations Lead

Summary

The job is for a Clinical Operations Lead who will oversee the operations of a clinical research project, provide oversight to assigned CRAs and investigator sites, develop study tools, review visit reports, and support other objectives for clinical operations. The role requires a college diploma/degree with 7-9 years of related experience or an undergraduate university degree with 4-6 years' experience.

Requirements

• College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading
• Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training

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
• Conduct assessment visits with CRAs
• Implement enrollment and recruitment strategies
• Prepare the monitoring plan and other structural documentation
• Oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions
• Develop study tools for site and CRA use
• Review visit reports, review and track protocol deviations
• Support other objectives for clinical operations and the clinical project team

Preferred Qualifications

• Health Sciences, Life Sciences or Nursing specialty preferred
• SoCRA and/or ACRP Certification/Designation
• 3 years CRA experience
• Proficient with EDC systems
• Proficient with MS Office
• Strong written and verbal communication skills
• Highly effective interpersonal and organizational skills

Benefits

• $75,000 - $124,000 a year
• Bonus