CRA I, no monitoring experience required

Syneos Health

Clinical Research Associate monitoring Australian clinical trials for Syneos Health, a biopharmaceutical solutions provider. Conducting site visits, source-data review, compliance checks, investigational-product oversight, and study documentation.

Posted 8/18/2026full-timeRemote • 🇦🇺 AustraliaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in site management, compliance with ICH/GCP guidelines, and effective communication with site personnel. Proficient in clinical data integrity, query resolution, and supporting audit readiness throughout the study lifecycle.

Highest-signal resume keywords

Site ManagementICH/GCP Guidelines KnowledgeClinical Data IntegrityQuery Resolution TechniquesChart Abstraction

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site QualificationSite InitiationInterim MonitoringSource Document ReviewData CollectionProtocol ComplianceInvestigational Product ManagementElectronic Data Capture ComplianceClinical Project Data ReviewAction Plan Development

Soft Skills

Excellent CommunicationPresentation SkillsInterpersonal SkillsAdaptabilityTeam Collaboration

Tools & Technologies

Tracking SystemsClinical Trial Management SoftwareData Review SoftwareElectronic Data Capture Systems

Certifications & Qualifications

Bachelor’s DegreeRN in a Related Field

Industry Keywords

Good Clinical PracticeRegulatory RequirementsReal World Late Phase StudiesSite Staff TrainingAudit Readiness

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Perform site qualification, site initiation, interim monitoring, site management, and close-out visits on-site or remotely
Evaluate site and site staff performance and provide recommendations and action plans
Maintain knowledge of ICH/GCP guidelines, applicable regulations, and company SOPs/processes
Verify informed consent, confidentiality, subject safety, clinical data integrity, and protocol compliance
Assess site processes and conduct source document review of site source documents and medical records
Verify clinical data entered in case report forms is accurate and complete
Apply query resolution techniques and drive query resolution to closure within agreed timelines
Use hardware and software for clinical project data review and capture
Verify compliance with electronic data capture requirements
Perform investigational product inventory, reconciliation, storage, dispensing, administration, labelling, import, and return reviews as applicable
Review Investigator Site Files and reconcile them with the Trial Master File
Ensure essential documents are archived according to local guidelines and regulations
Document activities through confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
Support subject/patient recruitment, retention, and awareness strategies
Track observations, ongoing status, and action items through tracking systems
Manage site-level activities and communications to meet project objectives, deliverables, budgets, and timelines
Act as liaison with project site personnel, independently or with another CRA or Central Monitoring Associate
Ensure assigned sites and project-specific site team members are trained and compliant
Prepare for and attend Investigator Meetings, sponsor meetings, global monitoring meetings, and clinical training
Support audit readiness, audit preparation, and follow-up actions
For Real World Late Phase, support the study lifecycle from site identification through close-out, chart abstraction, data collection, and collaboration with sponsor affiliates, medical science liaisons, and local country staff

Requirements

What you’ll need

Bachelor’s degree or RN in a related field, or equivalent combination of education, training and experience
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Good computer skills and ability to embrace new technologies
Excellent communication, presentation, and interpersonal skills
Ability to manage required travel of up to 75% on a regular basis
For Real World Late Phase: knowledge of local requirements for real world late phase study designs
For Real World Late Phase: chart abstraction and data collection capabilities
Ability to adapt to changing priorities under the oversight of the Lead CRA
Ability to ensure assigned sites and project-specific site team members are trained and compliant with applicable requirements

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Total Self culture
Diversity, inclusion, and belonging initiatives
Comprehensive resources including emerging technologies, data, science and knowledge sharing
Reasonable accommodations, when appropriate