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Clinical Research Associate II
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 aspects of global projects, including onsite monitoring, regulatory support, and site communication. Proficient in ensuring compliance with clinical research standards while maintaining strong relationships with clinical sites and investigators.
Highest-signal resume keywords
On-Site Monitoring ExperienceClinical Research StandardsRegulatory Document PreparationCommunication SkillsBudget Negotiation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
CRF ReviewSource Document VerificationQuery ResolutionFeasibility ResearchClinical Trial MonitoringData Quality CompliancePhase II MonitoringPhase III MonitoringExperience in Inflammatory Bowel DiseaseExperience in Oncology
Soft Skills
CommunicationCollaborationProblem-SolvingMultitaskingTeamwork
Tools & Technologies
MS WordMS ExcelMS PowerPoint
Industry Keywords
Life SciencesPharmacyClinical TrialsAustraliaInfectious Diseases
About the role
Key responsibilities & impact- Manage the clinical aspects of full-service global projects in Australia
- Conduct and report all types of onsite monitoring visits
- Participate in study startup
- Perform CRF review, source document verification, and query resolution
- Facilitate site budgets and contract negotiations
- Monitor trial progress at the country level
- Manage site communication
- Serve as a point of contact for in-house support services and vendors
- Communicate with internal project teams regarding study progress
- Participate in feasibility research
- Support the regulatory team in preparing documents for study submissions
- Build and maintain relationships with clinical sites and investigators
- Ensure timelines, targets, and clinical research standards
- Focus on subjects’ rights, safety, well-being, and data quality compliance
Requirements
What you’ll need- College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
- At least 2 years of independent on-site monitoring experience in Australia
- Experience in all types of monitoring visits in Phase II and/or III
- Experience in Inflammatory Bowel Disease, Oncology, or Infectious Diseases is a plus
- Full working proficiency in English
- PC skills to be able to work with MS Word, Excel and PowerPoint
- Ability to plan, multitask and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
- Ability to travel
Benefits
Comp & perks- Competitive salary
- Hybrid work arrangement: 2 days flexi and 3 days in office
- Onsite Gym access
- 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
- Career growth opportunities