Senior CRA - Remote (Romania) | Clinical Monitoring Expert

Syneos Health, Inc.; Ro; Remote; EUR 45,000 - 65,000; Full time

Job summary

Syneos Health, Inc. is seeking a Sr CRA for a Homebased role across Romania. You will perform site qualification, initiation, interim monitoring, and close-out visits, ensuring regulatory compliance and GCP with the CMP/SMP.

You will verify informed consent, protect patient data, review source documents, manage data queries remotely or on-site, and support site staff to achieve study milestones within timelines.

Qualifications

• Bachelor's degree or RN in related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking expected.
• Ability to manage required travel of up to 75% on a regular basis.

Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (on-site or remote) ensuring regulatory, ICH-GCP and/or GPP compliance.
• Verifies informed consent and protects confidentiality of subjects/patients; assesses safety and data integrity factors.
• Assesses site processes, conducts Source Document Review, and ensures accurate CRF data via site documents.

Skills

Good communication

Travel up to 75%

GCP knowledge

Education

Bachelor's degree or RN

Job description

Syneos Health, Inc. is seeking a Sr CRA for a Homebased role across Romania. You will perform site qualification, initiation, interim monitoring, and close-out visits, ensuring regulatory compliance and GCP with the CMP/SMP.

You will verify informed consent, protect patient data, review source documents, manage data queries remotely or on-site, and support site staff to achieve study milestones within timelines.