Clinical Research Associate 2

This is a fully remote position, open to applicants in Australia.

📋 Description

• Oversee the identification and selection of investigators and trial sites, including conducting feasibility assessments.

• Execute monitoring activities in accordance with the Monitoring Plan and generate prompt monitoring visit reports.

• Organize and carry out site evaluation visits, providing reports on findings to assist with site selection.

• Prepare and manage regulatory packages, import/export requirements, and updates for Ethics Committee submissions.

• Negotiate site budgets, manage site contracts, monitor invoicing, and ensure prompt payments to sites.

• Plan and execute site initiation visits.

• Create and maintain monitoring tools along with project-specific documentation.

• Inspire and train investigators and site staff on protocols, investigational products, and trial necessities.

• Gather, review, approve, and code essential trial-site documents for filing in the Trial Master File.

• Reconcile the contents of the in-house Trial Master File with Investigator Site Files.

• Manage the distribution, tracking, handling, and disposal of investigational products and trial supplies.

• Maintain trial information within the clinical trial management system and other tracking/reporting tools.

• Assist in developing strategies to enhance trial recruitment.

⛳️ Requirements

• Tertiary qualifications in a relevant science or healthcare field.

• A minimum of 2 years' experience in on-site monitoring and site management within an academic, CRO, or pharmaceutical setting is essential.

• Experience in renal and/or oncology clinical trials is advantageous.

• Solid understanding of ICH-GCP guidelines as well as global and local ethical and regulatory research standards.

• Proficiency in ethical and participant safety considerations, site start-up and conduct management, risk management, quality management, supply management, scientific concepts, clinical research design, and escalation of issues.

• Skills in negotiation, conflict resolution, critical thinking, problem-solving, decision-making, and strategic thinking.

• Excellent interpersonal communication and presentation abilities.

• Flexibility to work effectively within a multidisciplinary team, independently, and with various stakeholders.

• Capacity to adapt to shifting organizational priorities and uncertain environments.

• Willingness and ability to travel as required.

🏝️ Benefits

• Competitive remuneration with a customized salary and benefits package.

• Options for hybrid or remote work arrangements, depending on location and role.

• Opportunities for learning and access to a worldwide network of scientific leaders.

• Employee wellness programs and initiatives promoting work-life balance, health, and team connectivity.

• Participation in global engagement surveys.

• Recognition initiatives.

• Team-building activities.

• Exposure to a variety of international projects and clients.