Clinical Research Associate

Role overview

IQVIA is hiring Clinical Research Associates to support its growing team across Australia. This role focuses on site monitoring and study management to help ensure clinical trials are run in line with the protocol, regulatory standards, and sponsor expectations.

What you will do

• Carry out site visits for selection, initiation, routine monitoring, and close-out, following the agreed scope of work and all relevant GCP and ICH requirements.
• Partner with study sites to shape, implement, and monitor subject recruitment plans so enrollment goals stay on track.
• Deliver protocol and study-related training to assigned sites and maintain regular communication to address issues and align expectations.
• Review site conduct and data quality to confirm that protocols and regulations are being followed, and raise quality concerns when needed.
• Track the status of regulatory submissions, approvals, recruitment, enrollment, CRF completion, data queries, and related study progress; may assist with start-up activities.
• Make sure required site records are collected for the Trial Master File and that the Investigator Site File is kept current and compliant with GCP and local rules.
• Prepare and maintain monitoring documentation, including visit reports, follow-up letters, and other required study records.
• Work closely with study team members to support effective project delivery.
• Where relevant, help develop site-level recruitment plans.
• Where relevant, support site financial administration, including invoice retrieval in line with local requirements and the clinical trial agreement.

What they are looking for

• A bachelor's degree in a scientific or healthcare-related field.
• At least 9 months of independent on-site monitoring experience.
• Relevant education, training, and experience may be accepted instead of a degree.
• Strong understanding of clinical research regulations, including GCP and ICH guidelines.
• Working knowledge of therapeutic areas and protocol execution, as provided through company training.
• Confident use of Microsoft Word, Excel, and PowerPoint, along with laptop and mobile devices such as iPhone and iPad where applicable.
• Good planning, organization, and problem-solving abilities.
• Strong time management and financial management skills.
• Ability to build effective working relationships with colleagues, managers, and clients.
• Candidates may be evaluated for different levels depending on total experience.

Benefits

• Flexible hybrid working, with office locations in central Melbourne and Sydney.
• Competitive pay plus car and health allowances.
• Opportunities to grow your career across FSO and FSP models.
• Exposure to skilled managers and multi-phase clinical trial work.

Additional information

Applicants should submit a resume if they meet the experience and skill requirements. IQVIA is a global clinical research organization focused on accelerating the development and commercialization of innovative treatments to improve patient outcomes and population health. The company maintains a strict zero-tolerance approach to candidate fraud. All information provided during recruitment must be accurate and complete; false statements, misrepresentation, or material omissions may lead to disqualification or termination, subject to applicable law.