Clinical Research Associate — Oncology Site Monitoring Pro

Parexel; Frankfort (KY); Presencial; USD 65.000 - 90.000; Jornada completa

Descripción de la vacante

Parexel is seeking a Clinical Research Associate to act as the primary site contact and site manager across all trial phases. The role emphasizes building strong site relationships, monitoring in alignment with ICH-GCP and SOPs, and coordinating with sponsor teams to ensure Site Ready status.

The candidate should have at least 2 years of direct site monitoring experience, a science-oriented bachelor’s degree, and be willing to travel domestically and internationally about 65–75% of the time.

Formación

• Minimum 2 years of direct site monitoring experience in bio/pharma/CRO.
• Bachelor’s degree preferred with a strong emphasis in science and/or biology.

Responsabilidades

• Acts as the primary site contact and site manager throughout all phases of a clinical study.
• Develops strong site relationships and ensures continuity of site relationships through the trial.
• Performs site monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws & regulations, protocol, and Site Monitoring Plan.
• Coordinates with sponsor roles to achieve Site Ready; conducts remote and on-site monitoring.
• Manages regulatory documentation for study start-up, maintenance and close-out; maintains data in systems.
• Communicates with investigators on protocol conduct, recruitment, deviations, and site performance.
• Identifies and resolves site performance or compliance problems and escalates as needed.
• Supports audits/inspections and co-monitoring visits where appropriate.

Conocimientos

Site monitoring

Regulatory knowledge

GCP/ICH compliance

Data management

Stakeholder communication

Travel 65-75%

Educación

Bachelor's degree in science or biology

Descripción del empleo

Parexel is seeking a Clinical Research Associate to act as the primary site contact and site manager across all trial phases. The role emphasizes building strong site relationships, monitoring in alignment with ICH-GCP and SOPs, and coordinating with sponsor teams to ensure Site Ready status.

The candidate should have at least 2 years of direct site monitoring experience, a science-oriented bachelor’s degree, and be willing to travel domestically and internationally about 65–75% of the time.