Clinical Research Associate II

Syneos Health; Sydney; Hybrid; AUD 90,000 - 120,000; Full time

Job summary

Syneos Health Australia Pty Ltd is seeking a clinical monitor to conduct site qualification, initiation, interim monitoring, management and close-out visits. These activities may be performed on-site or remotely, ensuring regulatory and protocol compliance with ICH-GCP and GPP standards.

The role requires careful judgment to evaluate site performance and staff, and to communicate/escalate issues and develop action plans.

Qualifications

• Minimum of 2+ years of independent clinical monitoring experience.
• Excellent communication and interpersonal skills with internal and external stakeholders.
• Knowledge of ICH-GCP Guidelines and related regulations is preferred.
• Full working rights in Australia or New Zealand (visa transfer sponsorship in AUS possible).

Responsibilities

• Perform site qualification, site initiation, interim monitoring, site management and close-out visits (on-site or remote).
• Maintain regulatory and protocol compliance, ensuring ICH-GCP/GPP adherence.
• Escalate serious issues to the project team and develop action plans.
• Provide site-level recommendations based on performance and risk assessments.

Skills

Independent clinical monitoring

Communication skills

Education

Bachelor's degree in Life Sciences

Job description

About You

Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed onsite or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.

Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.

Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.

Awesome line management supporting team with a huge focus on you!

Value your expertise, listen to your voice and most important work as a team

Forward thinking & innovative CRO which stands out in the industry

Bachelor's degree or College/University degree in Life Sciences or equivalent qualifications

Minimum of 2-years of independent clinical monitoring experience

Excellent communication and interpersonal skills with internal and external stakeholders

Good time management skills and demonstrate critical thinking

Full working rights in Australia or New Zealand (Open to Visa Transfer Sponsorship in AUS)

This opportunity is being advertised by Syneos Health Australia Pty Ltd.