Clinical Research Associate

Position Overview

IQVIA, a globally recognized Contract Research Organization (CRO), is seeking Clinical Research Associates (CRA) to join their teams in various locations across Australia, including Melbourne. This role involves monitoring and managing clinical trial sites to ensure compliance with protocols, regulations, and sponsor requirements.

Key Responsibilities

• Conduct site visits including selection, initiation, monitoring, and close-out in alignment with contractual and regulatory standards such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Collaborate with clinical sites to implement, drive, and monitor subject recruitment strategies that meet project goals.
• Provide protocol-specific training and maintain ongoing communication with site personnel to manage expectations and address issues.
• Assess site adherence to protocols and regulatory requirements, escalating quality concerns when necessary.
• Oversee study progress by tracking regulatory submissions, recruitment, case report form completion, and data query resolution; support study start-up as needed.
• Ensure proper documentation and maintenance of site files, including Trial Master File (TMF) and Investigator's Site File (ISF), complying with GCP and regulatory standards.
• Document site management activities, monitoring outcomes, and action plans through visit reports, follow-up correspondence, and other necessary study documents.
• Coordinate with study teams to facilitate project execution and may assist with site-specific recruitment planning and financial management according to clinical trial agreements.

Required Qualifications and Skills

• Bachelor's degree in a scientific or healthcare-related discipline, or equivalent education and experience.
• Minimum of 9 months’ experience performing independent on-site clinical monitoring.
• Solid understanding of clinical research regulations, including GCP and ICH guidelines.
• Therapeutic and protocol knowledge developed through company training.
• Proficiency in Microsoft Office applications and familiarity with laptop, iPhone, and iPad technologies where applicable.
• Strong organizational, problem-solving, time management, and financial management abilities.
• Capability to establish and maintain professional relationships with colleagues, supervisors, and clients.

Benefits and Additional Information

• Flexible work setting combining office presence (in Melbourne and Sydney) with hybrid working arrangements.
• Competitive remuneration package including car and health allowances.
• Opportunities for career advancement across Functional Service Provider (FSP) and Functional Service Outsourcing (FSO) models.
• Exposure to multi-phase clinical trials under guidance of experienced managers.

Integrity Statement

IQVIA maintains a strict zero-tolerance policy against any candidate fraud throughout the hiring process. All credentials and information submitted must be accurate and truthful; any discrepancies may lead to immediate application rejection or employment termination, consistent with legal guidelines.