Clinical Research Associate

About the Role

Join IQVIA, a globally recognized Contract Research Organization (CRO), as a Clinical Research Associate (CRA) based in Sydney, Australia. This role involves monitoring and managing clinical study sites to ensure research is conducted in compliance with protocols, regulations, and sponsor requirements.

Key Responsibilities

• Conduct site monitoring visits including site selection, initiation, routine monitoring, and close-out in line with contractual and regulatory guidelines such as Good Clinical Practice (GCP) and ICH standards.
• Collaborate with study sites to adapt and implement recruitment plans to meet project objectives efficiently.
• Provide protocol and study-related training to site personnel and maintain continuous communication to manage project expectations and resolve issues.
• Assess the quality and compliance of site practices, escalating concerns about protocol adherence and regulatory compliance when necessary.
• Track and manage study progress through regulatory submissions, recruitment, data entry (CRF completion), and query resolution, supporting start-up activities when required.
• Ensure proper documentation is filed in Trial Master Files (TMF) and Investigator Site Files (ISF) as per regulatory standards.
• Maintain documentation of monitoring visits, including reports, follow-up correspondence, and action plans.
• Work collaboratively with study teams to support project execution and potentially contribute to site-specific recruitment and financial management according to clinical trial agreements.

Required Qualifications and Skills

• Bachelor’s degree in a scientific or healthcare-related field or equivalent combination of education, training, and experience.
• A minimum of 9 months independent experience performing on-site monitoring visits.
• Sound understanding and application of clinical research regulations including GCP and ICH guidelines.
• Familiarity with therapeutic areas and protocol knowledge as obtained through company training.
• Proficiency in using software such as Microsoft Word, Excel, PowerPoint, and devices like laptops, iPhones, and iPads.
• Strong organizational, problem-solving, time management, and financial management skills.
• Ability to build and maintain effective working relationships with coworkers, managers, and clients.

Benefits and Work Environment

• Flexible hybrid work setting with offices located in central Melbourne and Sydney.
• Competitive remuneration package including car and health allowances.
• Opportunities for professional advancement within various operational models of the company.
• Engagement with experienced managers across multiple phases of clinical trials.

Additional Information

IQVIA upholds a zero tolerance approach to candidate misrepresentation. Honesty in the application process is mandatory; any falsification or omission may lead to disqualification or termination. This role offers a chance to contribute to groundbreaking healthcare research and improve patient outcomes on a large scale.