CRA II – SCRA I

Syneos Health

. Perform site qualification, site initiation, interim monitoring, site management and close-out visits on-site or remotely .

Posted 11/1/2026full-timeRemote • AustraliaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in site qualification, monitoring, and compliance with regulatory standards such as ICH-GCP/GPP. Proficient in managing clinical study data, ensuring data integrity, and supporting site-level activities and communications.

Highest-signal resume keywords

Site QualificationRegulatory ComplianceClinical Data IntegrityGood Clinical Practice KnowledgeExcellent Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site ManagementData ReviewSource Document ReviewElectronic Data Capture ComplianceInvestigational Product InventoryClinical MonitoringChart AbstractionData CollectionProtocol CompliancePerformance Evaluation

Soft Skills

Interpersonal SkillsCritical ThinkingPresentation SkillsMentorshipProblem-Solving

Tools & Technologies

Clinical Study SoftwareTracking SystemsData Capture HardwareTrial Master FilesInvestigator Site Files

Certifications & Qualifications

Bachelor’s DegreeRN in Related Field

Industry Keywords

ICH GuidelinesGCPRegulatory RequirementsClinical TrialsPatient Confidentiality

About the role

Key responsibilities & impact

Perform site qualification, site initiation, interim monitoring, site management and close-out visits on-site or remotely
Ensure regulatory, ICH-GCP/GPP and protocol compliance
Evaluate site and site staff performance and provide recommendations or escalate serious issues
Verify informed consent processes, subject/patient confidentiality, safety and clinical data integrity
Assess site processes and conduct source document review
Verify clinical data entered in case report forms against source documents and medical records
Resolve queries remotely and on site within agreed timelines
Use hardware and software for clinical study data review and capture
Verify electronic data capture compliance
Perform investigational product inventory, reconciliation, storage, security and dispensing reviews as applicable
Review Investigator Site Files and reconcile them with Trial Master Files
Document monitoring activities and maintain tracking systems
Support subject/patient recruitment, retention and awareness strategies
Manage site-level activities and communications to meet project objectives, deliverables and timelines
Liaise with project site personnel and ensure site team training and compliance
Prepare for and attend Investigator and sponsor meetings
Participate in or lead clinical monitoring/project staff meetings and attend clinical training
Support audit readiness and audit follow-up actions
Provide training or mentorship to junior CRAs and perform training/sign-off visits as assigned
For RWLP: support sites throughout the study lifecycle, perform chart abstraction and data collection, develop country-level informed consent forms, collaborate with regulatory teams, identify operational efficiencies, participate in bid defense meetings and suggest potential sites

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
Basic level of critical thinking skills
Ability to manage required travel of up to 75% on a regular basis

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Inclusive culture
Reasonable accommodations, when appropriate, for employees or applicants with disabilities