Clinical Research Associate

IQVIA

. Perform monitoring and site management work to ensure sites conduct studies and report study data according to protocol, regulations, guidelines and sponsor requirements .

Posted 10/9/2026full-timeMelbourne • AustraliaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical research site management, including monitoring, regulatory compliance, and effective communication with study sites. Proficient in managing site finances and recruitment plans while ensuring adherence to GCP and ICH guidelines.

Highest-signal resume keywords

Clinical Research MonitoringRegulatory ComplianceGCP and ICH GuidelinesSite ManagementSubject Recruitment Planning

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site MonitoringData Query GenerationProtocol AdministrationTrial Master File MaintenanceCRF CompletionStudy TrainingRegulatory SubmissionsStudy Start-Up SupportIndependent On-Site MonitoringTherapeutic Knowledge

Soft Skills

Organizational SkillsProblem-Solving SkillsTime ManagementFinancial ManagementInterpersonal Skills

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPointLaptop ComputerIPhoneIPad

Industry Keywords

Clinical ResearchSite ManagementStudy ProtocolQuality IssuesStudy Data Reporting

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Perform monitoring and site management work to ensure sites conduct studies and report study data according to protocol, regulations, guidelines and sponsor requirements
Perform site monitoring visits, including selection, initiation, monitoring and close-out visits
Adapt, drive and track subject recruitment plans
Administer protocol and study training to assigned sites and maintain communication with sites
Evaluate study-site practices for protocol and regulatory compliance and escalate quality issues
Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution
Support study start-up where applicable
Maintain site documents for the Trial Master File and verify Investigator's Site File maintenance
Document site management activities, monitoring findings and action plans through visit reports and follow-up letters
Collaborate with study team members to support project execution
Support development of site-level subject recruitment plans where applicable
Manage site finances and retrieve invoices according to local requirements where applicable

Requirements

What you’ll need

Bachelor's Degree in scientific discipline or health care, or equivalent combination of education, training and experience in lieu of degree
At least 9 months of independent on-site monitoring experience
Good knowledge of applicable clinical research regulatory requirements, including GCP and ICH guidelines
Good therapeutic and protocol knowledge as provided in company training
Proficiency in Microsoft Word, Excel and PowerPoint
Ability to use a laptop computer, iPhone and iPad where applicable
Organizational and problem-solving skills
Effective time and financial management skills
Ability to establish and maintain effective working relationships with coworkers, managers, and clients

Benefits

Comp & perks

Competitive salary with car and health allowances
Flexible hybrid work environment
Career growth and opportunity across FSO and FSP models
Work with skilled Managers across multi-phases clinical trials