Senior Clinical Research Associate I/II – FSP

Fortrea

. Monitor and manage clinical study sites, including initiation, routine visits, and closeout activities .

Posted 11/11/2026full-timeSydney • AustraliaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical monitoring and management, ensuring compliance with regulatory requirements and patient safety while effectively coordinating with teams and vendors. Proficient in data integrity verification and mentoring junior staff to enhance team capabilities.

Highest-signal resume keywords

Clinical Monitoring ExperienceRegulatory Requirements KnowledgeSite Monitoring SkillsCommunication AbilitiesData Integrity Verification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical MonitoringData VerificationProtocol ComplianceMonitoring Report PreparationFeasibility AssessmentBudget NegotiationRegulatory SubmissionCase Report Form (CRF) ReviewProject ManagementInformed Consent Compliance

Soft Skills

Organizational AbilitiesProblem-Solving SkillsMentoringTeam CoordinationCommunication Skills

Tools & Technologies

Computer ApplicationsClinical Trial Management Systems

Industry Keywords

Clinical ResearchPharmaceuticalCROPatient SafetyAudit ReadinessSite InitiationRoutine VisitsCloseout ActivitiesStudy Files MaintenanceTravel Requirements

About the role

Key responsibilities & impact

Monitor and manage clinical study sites, including initiation, routine visits, and closeout activities
Ensure patient safety and compliance with informed consent and protocol requirements
Review source documents and verify data integrity on Case Report Forms (CRFs)
Prepare accurate and timely monitoring reports and maintain study files
Serve as lead monitor for assigned protocols and assist in developing monitoring plans
Coordinate with vendors and internal teams to meet project timelines and objectives
Support feasibility assessments, budget negotiations, and regulatory submissions
Mentor and train junior team members through co-monitoring and guidance
Travel extensively (60–80%) to support site activities and maintain audit readiness

Requirements

What you’ll need

Bachelor’s degree in life sciences or related field, or equivalent clinical research experience
Typically a minimum 3 years of clinical monitoring experience in pharmaceutical or CRO settings
Strong knowledge of regulatory requirements and drug development processes
Advanced site monitoring and management skills
Excellent communication, organizational, and problem-solving abilities
Proficiency in relevant computer applications and systems
Valid driver’s license and ability to travel extensively
Ability to travel extensively (60–80%)

Benefits

Comp & perks

Access robust training, mentorship, and advancement opportunities
Collaborative, inclusive environment
Work-life balance
Contribute to groundbreaking research that improves lives worldwide