Senior CRA, Early Dev - Remote

Parexel; Columbus (OH); A distancia; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

Parexel is seeking a Senior Clinical Research Associate (SrCRA) to support monitoring and site management for sponsored studies in line with ICH GCP and applicable regulations. The role involves on-site and remote visits, collaboration with CTLs and cross-functional teams, and oversight of data quality and study conduct at investigator sites.

Responsibilities include preparing monitoring plans, reviewing study metrics, ensuring timely regulatory submissions, and maintaining clear, compliant site

Formación

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

Responsabilidades

• Perform site management activities to ensure protocol, plan, GCP, and local regulations compliance.
• Conduct site qualification, initiation, interim, and close-out visits on-site and remotely.
• Collaborate with CTLs and 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 with protocol-compliant storage/shipment.

Conocimientos

Communication

Interpersonal skills

Analytical thinking

Problem solving

Time management

Educación

Bachelor's degree or equivalent

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 sponsored studies in line with ICH GCP and applicable regulations. The role involves on-site and remote visits, collaboration with CTLs and cross-functional teams, and oversight of data quality and study conduct at investigator sites.

Responsibilities include preparing monitoring plans, reviewing study metrics, ensuring timely regulatory submissions, and maintaining clear, compliant site