Beschreibung

In this role, you will lead clinical operations for projects, ensuring compliance with protocols and regulations while supporting CRAs and the clinical project team. Daily responsibilities include training, monitoring site performance, and collaborating with various stakeholders to drive project success.

Anforderungen

• •College diploma/degree
• •7-9 years related experience
• •Undergraduate university degree (Bachelors or Honors Bachelors)
• •4-6 years' experience
• •Health Sciences, Life Sciences or Nursing specialty preferred
• •SoCRA and/or ACRP Certification/Designation
• •Minimum of 3 years CRA experience
• •Strong experience with EDC systems
• •Proficiency with MS Office
• •Strong written and verbal communication skills
• •Highly effective interpersonal and organizational skills
• •Proactivity
• •Detail orientation
• •Task-driven
• •Highly organized
• •Understanding of GCPs and local regulations
• •Clinical monitoring knowledge
• •Ability in report writing
• •Strong understanding of clinical research documents
• •Ability to handle multiple tasks
• •Ability to meet deadlines in a dynamic environment

Aufgaben

• •Oversee clinical operations for projects
• •Ensure compliance with study protocols and regulations
• •Act as a liaison between CRAs and the clinical project team
• •Provide project-specific training for CRAs
• •Conduct assessment visits with CRAs
• •Implement enrollment and recruitment strategies
• •Prepare monitoring plans and structural documentation
• •Schedule monitoring visits and track performance metrics
• •Manage issue escalation and corrective actions
• •Develop study tools for site and CRA use
• •Review visit reports for quality and compliance
• •Track protocol deviations
• •Support clinical operations objectives
• •Monitor regional CRA compliance with study timelines
• •Conduct co-monitoring visits as needed
• •Assist in vendor management activities
• •Proactively manage site and country performance
• •Contribute to financial project management processes
• •Manage investigator sites temporarily or permanently
• •Conduct regular global CRA calls
• •Attend meetings with Study Sponsor for status updates
• •Provide operational support to the monitoring team
• •Train and mentor regional CRAs on study procedures
• •Serve as the first point of contact for CRAs
• •Liaise with line managers for CRA assignments
• •Conduct CRA assessment visits to evaluate performance
• •Develop training materials and study tools
• •Create and present materials for Sponsor meetings

Benefits