CRA II: Site Monitoring Pro — Remote & Field

Syneos Health, Inc.; Sydney; Sur place; AUD 90 000 - 120 000; Plein temps

Résumé du poste

Syneos Health in Sydney is seeking a Clinical Research Associate to perform site qualification, initiation, monitoring, and close-out visits (on-site or remotely), ensuring regulatory compliance and data integrity. You will verify informed consent, conduct source document reviews, and manage queries with site staff.

The role requires knowledge of ICH-GCP standards, strong communication, and computer skills, with travel up to 75% to support sites and study teams across regions.

Qualifications

• Bachelor’s degree or RN in a 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.
• Good computer skills and ability to embrace new technologies.
• Ability to travel up to 75% on a regular basis.

Responsabilités

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.
• Verifies the process of obtaining informed consent and protects patient confidentiality.
• Conducts Source Document Review of site source documents and medical records; ensures CRF data accuracy.
• Applies query resolution techniques remotely and on site, driving closure within timelines.
• May perform IP inventory, reconciliation and reviews storage and security; ensures proper labelling and release.

Connaissances

Excellent communication, presentation,

Good computer skills

Willingness to travel

Formation

Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience

Description du poste

Syneos Health in Sydney is seeking a Clinical Research Associate to perform site qualification, initiation, monitoring, and close-out visits (on-site or remotely), ensuring regulatory compliance and data integrity. You will verify informed consent, conduct source document reviews, and manage queries with site staff.

The role requires knowledge of ICH-GCP standards, strong communication, and computer skills, with travel up to 75% to support sites and study teams across regions.