Clinical Research Associate I

Fortrea

. Support unblinded monitoring activities for FSP MSD clinical studies .

Posted 11/1/2026full-timeSydney • AustraliaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial monitoring, regulatory compliance, and data integrity management. Proficient in liaising with vendors, managing clinical site activities, and ensuring audit readiness while maintaining effective communication in both English and the local office language.

Highest-signal resume keywords

Clinical Trial MonitoringRegulatory ComplianceData Integrity ManagementClinical Trial Management System (CTMS)ICH GCP Understanding

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Site MonitoringSource Document ReviewCRF ReviewQuery GenerationSerious Adverse Event ReportingFeasibility AssessmentProtocol Compliance VerificationInformed Consent ProceduresClinical Research TerminologyBasic Physiology and Pharmacology Knowledge

Soft Skills

Planning SkillsOrganizational SkillsProblem-Solving SkillsTeam CollaborationEffective Communication

Tools & Technologies

Microsoft OfficePC LiteracyWindows Operating System

Certifications & Qualifications

University or College DegreeNursing Licensure

Industry Keywords

Regulatory GuidelinesClinical OperationsISO 14155Clinical ResearchAudit Readiness

About the role

Key responsibilities & impact

Support unblinded monitoring activities for FSP MSD clinical studies
Perform routine monitoring and closeout of clinical sites
Maintain study files and conduct pre-study and initiation visits
Liaise with vendors and manage site-related activities
Ensure study staff receive proper materials and instructions
Verify informed consent procedures and protocol compliance
Review source documents and ensure data integrity on CRFs and other data collection tools
Monitor missing or implausible data
Perform monitoring tasks efficiently according to SOPs and guidelines
Ensure audit readiness at the site level
Prepare accurate and timely trip reports
Interact with internal work groups to evaluate needs, resources, and timelines
Act as a contact for clinical trial supplies and vendors
Manage registries and undertake feasibility work when requested
Participate in and follow up on Quality Control Visits
Support investigator recruitment, EC submissions, regulatory notifications, document translation, and meeting organization
Assist the Senior CRA with investigator site budgets
Track and follow up on Serious Adverse Event reporting and related documentation
Perform CRF review, query generation, and query resolution in clinical data management systems
Assist with training, mentoring, and development of new employees through activities such as co-monitoring
Coordinate designated clinical projects as a Local Project Coordinator and act as a local client contact when assigned
Perform other duties assigned by management
Travel, including air travel, as an essential job function

Requirements

What you’ll need

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure); equivalent experience may be substituted
Relevant and equivalent experience may be accepted in lieu of educational requirements
Basic knowledge of Regulatory Guidelines
Basic understanding of the clinical trial process
Fluent in the local office language and English, written and verbal
Six (6) months experience in a related role
Ability to work within a project team
Good planning, organization, and problem-solving skills
Good computer skills and working knowledge of computer packages
Ability to work efficiently and effectively in a matrix environment
Valid Driver's License
Preferred: one or more additional years of experience in a related field
Preferred: six months of on-site monitoring experience
Ability to maintain confidentiality of data and information
Understanding of clinical operations activities
Understanding of medical and clinical research terminology and processes
Basic understanding of physiology, pharmacology, and medical devices when applicable
Understanding of ICH GCP, ISO 14155 when applicable, and regulatory requirements
PC, Windows, and Microsoft Office literacy
Effective English communication skills
Experience using a clinical trial management system (CTMS)

Benefits

Comp & perks

Hybrid work arrangement
Full-time employment
Travel expenses managed according to Fortrea travel policy