Remote Oncology CRA: Site Leadership & Monitoring

Parexel

Atlanta (GA)

À distance

USD 70 000 - 95 000

Plein temps

Il y a 3 jours
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Résumé du poste

Parexel is seeking a Clinical Research Associate to oversee site management and monitoring across trials. The role focuses on maintaining strong site relationships, ensuring protocol adherence, and safeguarding participant safety.

You will work across phases, manage regulatory docs, and collaborate with investigators and sponsor teams to drive study success. Ideal candidates have at least two years of direct site monitoring experience in bio/pharma/CRO, a science degree, and strong ICH-GCP

Qualifications

  • Bachelor’s degree in science, biology preferred.
  • Minimum 2 years of direct site monitoring experience in bio/pharma/CRO.
  • Experience with ICH-GCP and regulatory documentation.
  • Strong site relationship and communication skills.

Responsabilités

  • Act as the primary site contact and site manager through all phases of a study.
  • Perform site monitoring activities in compliance with ICH-GCP and sponsor SOPs.
  • Coordinate site readiness, initiation, monitoring, and closeout visits.
  • Collect, review, and maintain regulatory documents and TMF entries.
  • Communicate study issues to investigators and sponsor teams; escalate as needed.
  • Maintain site performance metrics and assist with audits/inspections.
  • Travel domestically and internationally as required (~65–75%).

Connaissances

Site management
Monitoring visits
GCP/ICH compliance
Regulatory documentation
Data management
Stakeholder communication
Travel readiness
Biopharma knowledge

Formation

Bachelor’s degree in science

Outils

CTMS

Description du poste

Parexel is seeking a Clinical Research Associate to oversee site management and monitoring across trials. The role focuses on maintaining strong site relationships, ensuring protocol adherence, and safeguarding participant safety.

You will work across phases, manage regulatory docs, and collaborate with investigators and sponsor teams to drive study success. Ideal candidates have at least two years of direct site monitoring experience in bio/pharma/CRO, a science degree, and strong ICH-GCP

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