Senior CRA, Early Development — Remote Monitoring Leader

Parexel; Carson City (NV); Híbrido; USD 110.000 - 140.000; Jornada completa

Descripción de la vacante

Parexel is seeking a Senior Clinical Research Associate (SrCRA) to support monitoring and site management for client-sponsored studies. This role ensures adherence to ICH GCP, local regulations, and client SOPs, with interactions at investigator sites on-site and remotely.

Collaboration with cross-functional teams and oversight of CRO-supported activities are key responsibilities. The SrCRA will review data, manage drug accountability, and ensure regulatory documents are current.

Formación

• Bachelor’s degree required.
• Minimum of 5 years of related experience for Snr CRA.
• Working knowledge of clinical drug development, ICH GCP, and regulatory requirements (FDA/EMA/PMDA).

Responsabilidades

• Perform site management and monitoring activities to ensure protocol and regulatory compliance.
• Conduct site qualification, initiation, interim, and close-out visits on-site and remotely.
• Review study metrics and identify sites for oversight monitoring visits.
• Write and submit monitoring visit reports and study correspondence timely.
• Maintain site regulatory files and ensure timely safety reporting.
• Identify deviations, elevate issues, and track corrective actions.
• Maintain communication with site staff, CTLs, and CRO CRAs.
• Support inspection readiness activities and data integrity.

Conocimientos

Effective communication

Interpersonal skills

Time management

Problem solving

Educación

Bachelor's degree

Herramientas

Microsoft Office

EDC

CTMS

Data repositories

Descripción del empleo

Parexel is seeking a Senior Clinical Research Associate (SrCRA) to support monitoring and site management for client-sponsored studies. This role ensures adherence to ICH GCP, local regulations, and client SOPs, with interactions at investigator sites on-site and remotely.

Collaboration with cross-functional teams and oversight of CRO-supported activities are key responsibilities. The SrCRA will review data, manage drug accountability, and ensure regulatory documents are current.