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Clinical Research Associate II
PSI CRO AGClinical Research Associate managing monitoring tasks and clinical studies at PSI. Ensuring high quality standards and supporting regulatory submissions in various therapeutic areas at PSI.
About the role
Key responsibilities & impact- Conduct and report all types of onsite monitoring visits
- Be involved in study startup
- Perform CRF review, source document verification and query resolution
- Be responsible for site communication and management
- Be a point of contact for in-house support services and vendors
- Communicate with internal project teams regarding study progress
- Participate in feasibility research
- Support regulatory team in preparing documents for study submissions
Requirements
What you’ll need- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Independent on-site monitoring experience in France
- Experience in all types of monitoring visits in Phase II and/or III
- Experience in oncology, hemophilia, infectious diseases, GI
- Full working proficiency in English
- Proficiency in MS Office applications
- Ability to plan, multitask and work in a dynamic team environment
Benefits
Comp & perks- Big professional advancement opportunity within Clinical Operations with specific mentorship and training program
- Development opportunities across PSI departments
- Flexible working hours
- Home-office option available, as well as combination of home and office work arrangement
- Extensive onboarding trainings and professional development training programs
- Highly developed company culture and positive team atmosphere
- Additional leave days (12 days of RTT)
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Onsite MonitoringCRF ReviewSource Document VerificationQuery ResolutionFeasibility ResearchStudy StartupRegulatory DocumentationPhase II MonitoringPhase III MonitoringOncology Experience
Soft Skills
CommunicationMultitaskingTeam CollaborationPlanning