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Clinical Research Associate II / Senior CRA
PSI CRO AG. Conduct and report all types of onsite monitoring visits .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in conducting onsite monitoring visits and managing site communications for clinical studies, with a strong focus on regulatory compliance and high-quality standards across various therapeutic indications.
Highest-signal resume keywords
On-Site Monitoring ExperiencePhase II And III MonitoringClinical Research FamiliarityRegulatory Document PreparationFull Working Proficiency In English
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 ResearchStudy Startup
Soft Skills
Communication SkillsCollaboration SkillsProblem-Solving SkillsAbility To MultitaskDynamic Team Environment
Tools & Technologies
MS Office Applications
Industry Keywords
Life SciencesOncologyHemophiliaInfectious DiseasesGastrointestinal Diseases
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
- Work on clinical studies across different therapeutic indications while maintaining high quality standards
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
- Communication, collaboration, and problem-solving skills
- Ability to travel
- Please submit your CV/resume in English
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
- Combination of home and office work arrangement
- Extensive onboarding trainings
- Professional development training programs
- Highly developed company culture and positive team atmosphere
- Additional leave days (12 days of RTT)