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Senior Clinical Research Associate
PSI CRO AG. Manage the clinical aspects of full-service global projects in Australia .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical research projects, ensuring compliance with timelines and quality standards while maintaining strong relationships with stakeholders. Proficient in monitoring visits, training, and supporting regulatory affairs within the clinical research domain.
Highest-signal resume keywords
Clinical Project ManagementOn-Site Monitoring ExperienceTraining and MentoringRegulatory ComplianceCommunication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical ResearchMonitoring VisitsCRF ReviewSource Document VerificationQuery ResolutionData ComplianceFeasibility ResearchPresentation SkillsAutomated Tracking SystemsPhase II and III Monitoring
Soft Skills
CollaborationProblem-SolvingInterpersonal SkillsTeamworkDynamic Planning
Tools & Technologies
MS Office Applications
Industry Keywords
Life SciencesClinical TrialsInflammatory Bowel DiseaseOncologyInfectious Diseases
About the role
Key responsibilities & impact- Manage the clinical aspects of full-service global projects in Australia
- Work on the frontline of communication with project stakeholders
- Ensure timelines, targets and standards of clinical research projects
- Build and maintain relationships with clinical sites and investigators
- Focus on subjects’ rights, safety and well-being and quality of data compliance
- Train, mentor and supervise study-level responsibilities for Jr. CRAs
- Prepare, conduct and report selection, initiation, routine and closeout monitoring visits
- Deliver training to investigators, site staff and project teams
- Work with complex studies
- Perform CRF review, source document verification and query resolution
- Manage site communication
- Participate in site identification and feasibility research
- Prepare and deliver presentations at Investigator’s Meetings
- Prepare for and attend company audits and resolve audit findings
- Support Regulatory Affairs in procuring site regulatory documents
- Maintain study-specific automated tracking systems
Requirements
What you’ll need- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- At least 4 years of independent on-site monitoring experience in Australia
- Experience in all types of monitoring visits in Phase II and/or III
- Availability to travel
- Experience in Inflammatory Bowel Disease, Oncology, Infectious Diseases is a plus
- Proficiency in MS Office applications
- Ability to plan and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
Benefits
Comp & perks- Competitive salary
- Hybrid work arrangement - 2 days flexi and 3 days in office (Sydney-based only)
- Onsite Gym access (Sydney-based only)
- Additional 5 days of wellness leave
- Development and learning opportunities
- Chance to make a real impact in a meaningful industry
- Continuous support from global peers
- On-the-job learning experiences
- Formal development programs
- Variety of opportunities to continue to grow throughout their career