Senior Clinical Monitoring Specialist

Planet Pharma; Austin (TX); Presencial; USD 76.000 - 85.000; Jornada completa

Descripción de la vacante

Planet Pharma is seeking a Clinical Monitoring professional to coordinate site management and monitoring activities, ensuring protocol compliance, data integrity, and audit readiness. Role involves remote and on-site visits, risk-based monitoring, and collaboration with sponsors across environments.

Responsibilities include monitoring sites, updating CTMS, and ensuring regulatory documents are complete while supporting project communications and process improvements.

Formación

• Minimum 2+ years as a clinical research monitor.
• Bachelor’s degree in life sciences or RN certification.
• Valid driver’s license where applicable.

Responsabilidades

• Monitor investigator sites using a risk-based approach and perform RCA.
• Perform on-site or remote monitoring and ensure data accuracy.
• Maintain trial documentation and participate in site visits.
• Provide trial status updates to the Clinical Team Manager and update CTMS.
• Ensure essential documents are complete per ICH-GCP and regulations.
• Contribute to project publications/tools and support team communications.
• Respond to audits/inspections and ensure compliance.

Conocimientos

Clinical monitoring

ICH GCP knowledge

Communication skills

Microsoft Office

Time management

Attention to detail

English proficiency

Team collaboration

Adaptability

Educación

Bachelor’s degree in life sciences

Registered Nursing certification

Herramientas

CTMS

Descripción del empleo

Planet Pharma is seeking a Clinical Monitoring professional to coordinate site management and monitoring activities, ensuring protocol compliance, data integrity, and audit readiness. Role involves remote and on-site visits, risk-based monitoring, and collaboration with sponsors across environments.

Responsibilities include monitoring sites, updating CTMS, and ensuring regulatory documents are complete while supporting project communications and process improvements.