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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.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in onsite monitoring, including CRF review and source document verification, while effectively managing site communications and supporting regulatory submissions. Proficient in conducting monitoring visits across various therapeutic areas, particularly in oncology and infectious diseases.
Highest-signal resume keywords
Onsite Monitoring ExperienceCRF ReviewSource Document VerificationRegulatory Submission SupportPhase II and III Monitoring
ATS Keywords
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Hard Skills
Onsite MonitoringCRF ReviewSource Document VerificationQuery ResolutionFeasibility ResearchStudy StartupRegulatory DocumentationPhase II MonitoringPhase III MonitoringOncology Experience
Soft Skills
CommunicationMultitaskingTeam CollaborationPlanning
Tools & Technologies
MS Office
Industry Keywords
Life SciencesHemophiliaInfectious DiseasesGastrointestinal DiseasesStudy Management
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)