Senior Clinical Research Associate II | Remote/Hybrid

Syneos Health Australia Pty Ltd; Melbourne, Sydney; Remote; AUD 90,000 - 120,000; Full time

Job summary

Syneos Health is seeking a CRA II/ SCR A I for Melbourne/Sydney home-based work to monitor sites across Australia. You will ensure regulatory and GCP compliance, perform site visits (onsite or remote) and support data integrity and patient safety.

The role requires strong communication skills, knowledge of ICH-GCP guidelines, and up to 75% travel. A Bachelor’s degree or RN is required, with the opportunity to develop within a global life sciences services organization.

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
• Must demonstrate good computer skills and be able to embrace new technologies
• Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills 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 processes and protects subject confidentiality
• Reviews CMP/SMP plans and conducts source data verification and query resolution
• Maintains Investigator Site File accuracy and archiving in TMF as required
• Supports subject recruitment, retention and data tracking
• Attends investigator meetings and participates in training and audit readiness activities
• May mentor junior CRAs and assist with training

Skills

Site monitoring

Regulatory knowledge

Communication

GCP/ICH familiarity

Travel readiness

Education

Bachelor degree or RN

Tools

Computer skills

Job description

Syneos Health is seeking a CRA II/ SCR A I for Melbourne/Sydney home-based work to monitor sites across Australia. You will ensure regulatory and GCP compliance, perform site visits (onsite or remote) and support data integrity and patient safety.

The role requires strong communication skills, knowledge of ICH-GCP guidelines, and up to 75% travel. A Bachelor’s degree or RN is required, with the opportunity to develop within a global life sciences services organization.