Senior Clinical Research Associate I Melbourne Home Based …, Adelaide

Senior Clinical Research Associate I (Melbourne – home based)

Job Overview

Roles within the Clinical Monitoring/CRA job family are responsible for monitoring during clinical research studies to ensure that the trials are conducted in accordance with widely accepted clinical practices. This includes on‑site and remote monitoring, developing tools, procedures and processes to ensure quality monitoring.

Job Responsibilities

Perform site qualification, site initiation, interim monitoring, site management and close‑out visits (onsite or remotely) ensuring regulatory, ICH‑GCP and Positive Pharmacoepidemiology Practices (GPP) and protocol compliance.

Use judgment to evaluate overall performance of sites and site staff, provide recommendations for site‑specific actions, communicate or escale serious issues to the project team and develop action plans.

Maintain a working knowledge of ICH/GCP guidelines and other applicable guidance, regulations, and company SOPs/processes.

Qualifications

Bachelor’s degree or equivalent in Life Sciences or related field.

Minimum of 4 years of independent clinical monitoring experience.

Excellent communication and interpersonal skills with internal and external stakeholders.

Good time‑management skills and critical‑thinking ability.

Full working rights in Australia or Current Zealand (open to visa transfer sponsorship in Australia).

Equal Prospect and Disability Statement

Any language in this description is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including compliance with the Americans with Disabilities Act, and the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform essential job functions.

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