Senior CRA, Early Development - Remote Oversight

Parexel; Salt Lake City (UT); A distancia; USD 95.000 - 125.000; Jornada completa

Descripción de la vacante

Parexel in the United States is seeking a Senior CRA to support monitoring and site management for client-sponsored studies. You will perform site qualification, initiation, ongoing monitoring, and close-out visits, on-site and remotely, ensuring adherence to ICH GCP and regulatory requirements.

You will collaborate with CTLs and cross-functional teams, review monitoring data, prepare reports, and help ensure study deliverables are met on time while maintaining data integrity and audit readiness.

Formación

• Minimum 5 years of related experience for Sr CRA.
• Strong knowledge of ICH GCP guidelines and regulatory requirements.
• Working knowledge of clinical drug development process.

Responsabilidades

• Perform site management and monitoring activities per protocol and ICH GCP.
• Conduct site qualification, initiation, interim, and close-out visits on-site or remotely.
• Review site data for accuracy and ensure timely documentation and reporting.
• Prepare oversight monitoring plans and monitor CRO/CRA activities.
• Support inspection readiness and data integrity at investigator sites.

Conocimientos

Analytical problem-solving

Effective communication

Time management

Educación

Bachelor's degree

Herramientas

Microsoft Office

EDC

CTMS

Descripción del empleo

Parexel in the United States is seeking a Senior CRA to support monitoring and site management for client-sponsored studies. You will perform site qualification, initiation, ongoing monitoring, and close-out visits, on-site and remotely, ensuring adherence to ICH GCP and regulatory requirements.

You will collaborate with CTLs and cross-functional teams, review monitoring data, prepare reports, and help ensure study deliverables are met on time while maintaining data integrity and audit readiness.