Clinical Research Associate II

TL;DR

Clinical Research Associate II (Oncology): Oversee study site management for clinical trials with an accent on patient safety, data quality, and regulatory compliance. Focus on conducting site visits, monitoring protocol adherence, resolving issues, and ensuring audit readiness across multiple studies.

Remote, Australia

Company

hirify.global is a CRO integrating clinical trial execution with scientific knowledge, laboratory expertise, and data sciences, focused on oncology and rare diseases.

What you will do

• Oversee site management to protect patient safety and ensure high data quality with low query levels.
• Conduct all types of site visits (pre-study, initiation, monitoring, close-out) and prepare accurate monitoring reports.
• Manage site start-up, regulatory submissions, informed consent processes, and investigator contracts if required.
• Review and reconcile Investigator Site File with Trial Master File, track trial tools, and support recruitment strategies.
• Handle investigational product inventory, SAE reporting, risk identification, and escalation.
• Communicate proactively with sites and project teams, attend meetings, and travel as needed (60-70%).

Requirements

• Location: Remote from Australia
• Travel required (60-70%)
• Bachelor's degree or equivalent in business, scientific, or healthcare discipline.
• Minimum 2 years on-site monitoring experience (1 year oncology and Phase I preferred).
• Fluency in English (verbal and written).
• Proficiency in Microsoft Office; knowledge of drug development process and ICH-GCP.

Nice to have

• Solid clinical research experience.
• Excellent organizational skills and ability to work remotely.

Culture & Benefits

• Team-oriented environment valuing flexibility, teamwork, and customer service.
• Opportunities for input and idea nurturing impacting company change.
• Focus on professional consistency with Precision Principles.