Senior CRA, Early Development (Remote)

Parexel; Montpelier (VT); A distancia; USD 90.000 - 140.000; Jornada completa

Descripción de la vacante

Parexel is seeking a Sr CRA to support monitoring and site management for client-sponsored studies. Role covers on-site and remote activities, with CTMS documentation and collaboration across study teams to meet deliverables.

Responsibilities include site visits, data reconciliation, and preparation of monitoring and oversight reports, while ensuring adherence to ICH GCP and regulatory standards.

Formación

• Bachelor's degree (or equivalent).
• Minimum of 5 years of related experience for Sr CRA.
• Strong analytical problem-solving skills and critical thinking abilities.
• Working knowledge of the clinical drug development process, ICH GCP guidelines, and applicable regulatory requirements (FDA, EMA, PMDA).

Responsabilidades

• Site management and monitoring to ensure compliance with protocol, monitoring plan, ICH GCP, and regulations.
• Perform site qualification, initiation, interim, and close-out visits, on-site and remote.
• Review site data and ensure accurate documentation and reporting.
• Maintain oversight of study metrics and site performance with CROs and investigators.
• Support inspection readiness and regulatory binder completeness.

Conocimientos

Site monitoring

ICH GCP knowledge

Regulatory compliance

Cross-functional collaboration

Communication skills

Educación

Bachelor's degree

Herramientas

CTMS

EDC

Microsoft Office

Descripción del empleo

Parexel is seeking a Sr CRA to support monitoring and site management for client-sponsored studies. Role covers on-site and remote activities, with CTMS documentation and collaboration across study teams to meet deliverables.

Responsibilities include site visits, data reconciliation, and preparation of monitoring and oversight reports, while ensuring adherence to ICH GCP and regulatory standards.