Senior CRA, Early Development – Remote

Parexel; Honolulu (HI); A distancia; USD 100.000 - 140.000; Jornada completa

Descripción de la vacante

Parexel is seeking a Senior Clinical Research Associate to support site management and monitoring for sponsor-led studies. The role will ensure compliance with ICH GCP, regulatory requirements, and client SOPs, with activities conducted on-site and remotely.

You will collaborate with CTLs and study teams to activate sites, review data quality, and maintain oversight through monitoring visits and accurate documentation. Strong regulatory knowledge and communication skills are essential.

Formación

• Minimum of 5 years of related experience for Sr CRA.
• Strong analytical problem-solving skills.
• Working knowledge of FDA, EMA, PMDA guidelines and regulatory requirements.

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.
• Collaborate with CTL and other client functions to support site activation and deliverables.
• Maintain productive relationships with investigator site staff and ensure effective communication.
• Review site source documentation and verify accurate data capture (ALCOA principles).
• Prepare and maintain Oversight Monitoring Plan and review study metrics.

Conocimientos

Communication

Analytical thinking

Time management

Regulatory knowledge

Educación

Bachelor's degree

Herramientas

CTMS

EDC

Microsoft Office

Descripción del empleo

Parexel is seeking a Senior Clinical Research Associate to support site management and monitoring for sponsor-led studies. The role will ensure compliance with ICH GCP, regulatory requirements, and client SOPs, with activities conducted on-site and remotely.

You will collaborate with CTLs and study teams to activate sites, review data quality, and maintain oversight through monitoring visits and accurate documentation. Strong regulatory knowledge and communication skills are essential.