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 +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
Benefits
Home-based
