Clinical Research Associate

IQVIA

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

Posted 9/19/2026full-timeMelbourne • AustraliaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in site management and monitoring within clinical research, ensuring compliance with regulatory requirements and effective communication with study sites. Proficient in managing project execution, subject recruitment, and maintaining study documentation.

Highest-signal resume keywords

Site Monitoring ExperienceKnowledge of GCP and ICH GuidelinesProject Execution SupportSubject Recruitment PlanningBachelor's Degree in Scientific Discipline

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site ManagementData Query GenerationRegulatory Submissions TrackingCRF CompletionProtocol Knowledge

Soft Skills

Organizational SkillsProblem-Solving SkillsEffective CommunicationTime ManagementFinancial Management

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPointLaptop ComputerIPhoneIPad

Industry Keywords

Clinical ResearchStudy Site ManagementTrial Master FileInvestigator's Site FileSubject Recruitment

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Perform monitoring and site management work to ensure study sites conduct studies and report data according to protocol, regulations, guidelines, and sponsor requirements
Perform site monitoring visits, including selection, initiation, monitoring, and close-out visits
Drive and track subject recruitment plans
Administer protocol and study training to assigned sites
Establish regular communication with sites to manage project expectations and issues
Evaluate study-site quality and integrity and escalate quality issues
Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution
Support the study start-up phase where applicable
Ensure site documents are available for Trial Master File filing 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 project subject recruitment plans on a per-site basis where applicable
Support site financial management and retrieve invoices according to local requirements where applicable

Requirements

What you’ll need

Bachelor's Degree in scientific discipline or health care
At least 9 months of independent on-site monitoring experience
Equivalent combination of education, training and experience may be accepted in lieu of degree
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
Experience using a laptop computer and 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

Flexible hybrid work environment
Competitive salary with car and health allowances
Career growth and opportunity across FSO and FSP models