Senior Phase I CRA: Site Monitoring & Oversight

Parexel; United States; Remoto; USD 90.000 - 130.000; Tempo integral

Resumo da vaga

Parexel is seeking a Sr CRA to lead site management and monitoring activities across sponsored studies, ensuring compliance with ICH-GCP and regulatory requirements. You will collaborate with CTLs, CROs, and investigator sites, manage data, safety, and study documents, and help drive study timelines.

The role involves on-site and remote monitoring, strong analytical skills, and effective communication to ensure quality deliverables and inspection readiness.

Qualificações

• Bachelor's degree (or equivalent) required.
• 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

• Perform site management activities to ensure protocol, monitoring plan and regulatory compliance.
• Conduct site qualification, initiation, interim, and close-out visits, on-site and remote.
• Partner with CTL and other client functions to support site activation and deliverables.
• Establish and maintain productive relationships with investigator site staff and ensure effective communication.
• Perform drug accountability, reconciliation, and destruction in line with storage/shipment requirements.
• Prepare and maintain Oversight Monitoring Plan.
• Review study metrics and site performance and identify sites for oversight visits.
• Review site source documentation and verify data accuracy (ALCOA).
• Write and submit monitoring visit reports and oversight reports.
• Ensure site regulatory files are current and timely submitted; safety reporting.
• Identify deviations, escalate non-compliance, and resolve issues.
• Maintain ongoing communication with site personnel, study teams, and CRO CRAs.
• Support inspection readiness activities and data integrity.

Conhecimentos

Analytical problem solving

Communication

Time management

Interpersonal skills

Critical thinking

Formação

Bachelor's degree (or equivalent)

Ferramentas

Microsoft Office

EDC

CTMS

Data repositories

Descrição da vaga

Parexel is seeking a Sr CRA to lead site management and monitoring activities across sponsored studies, ensuring compliance with ICH-GCP and regulatory requirements. You will collaborate with CTLs, CROs, and investigator sites, manage data, safety, and study documents, and help drive study timelines.

The role involves on-site and remote monitoring, strong analytical skills, and effective communication to ensure quality deliverables and inspection readiness.